Digestive & Liver Diseases Clinical Trials

Working together to constantly improve your diagnostic and treatment options, doctors and researchers at Cedars-Sinai are leaders in the field of gastroenterological disorders and gastrointestinal surgery. Hospitals around the world consult with our teams because of their expertise and history of groundbreaking discoveries. As a patient here, you'll have access to ongoing clinical trials and advanced research that provides treatment options to further advance your care—sometimes before it is widely available to others.

Questions? See the Clinical Trials FAQs.


Click below to view clinical trials by areas:

Fatty Liver

Condition:

Nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • 18-75 years old
  • Groups 1-6:
    • Diagnosis of nonalcoholic fatty liver disease
    • Screening FibroTest <0.75
    • Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% steatosis
    • Screening magnetic resonance elastography (MRE) with liver stiffness ≥2.88 kPa, or
    • Historical liver biopsy consistent with NASH with stage 2-3 fibrosis, and
    • No documented weight loss >5% between the date of the liver biopsy and screening

Summary:

The purpose of this study is to evaluate the experimental drugs selonsertib (SEL; formerly GS-4997), GS-0976 and GS-9674 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a disease that results when fat accumulates in the liver. The body’s immune system may respond to the fat by attacking liver cells and over time, scar tissue (fibrosis) forms. SEL, GS-0976 and GS-9674 are intended to reduce inflammation, fibrosis, and fat buildup in the liver. Researchers will assess the safety, tolerability and effectiveness of these drugs in NASH patients.

Condition:

Nonalcoholic Steatohepatitis

Key Inclusion Criteria:

  • 18-75 years old
  • Confirmation of steatohepatitis on a diagnostic liver biopsy
  • Fibrosis Stage 1 or greater and below Stage 4 (according to the NASH Clinical Research Network fibrosis staging system)
  • Body mass index ≤45 kg/m²

Summary:

This study focuses on patients diagnosed with nonalcoholic steatohepatitis (NASH) with fibrosis (recently confirmed by a liver biopsy) or those who are at high risk of having this disease and are willing to undergo a liver biopsy to determine whether they have NASH with fibrosis. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called elafibranor in these patients. Researchers will assess the efficacy of elafibranor compared to placebo (inactive substance) for the treatment of NASH. The study will also evaluate whether elafibranor reduces the number of patients that will develop further complications from NASH, such as liver cirrhosis.

Condition:

Nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and bridging (F3 fibrosis)
  • Meets specific laboratory parameters at the screening visit

Summary:

This study focuses on patients who have advanced liver fibrosis without cirrhosis as a result of nonalcoholic steatohepatitis (NASH). The study will test an experimental drug called selonsertib for the treatment of advanced liver fibrosis due to NASH. NASH is a disease that results when fat accumulates in the liver; the body’s immune system may respond by attacking the liver cells. Selonsertib is being developed to reduce inflammation and fibrosis in the liver. Researchers will assess the effects, safety and tolerability of selonsertib , as well as whether it can reduce fibrosis and associated complications in patients with cirrhosis and fibrosis due to NASH.

Condition:

Nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and cirrhosis
  • Meets specific laboratory parameters at the screening visit
  • Males and non-pregnant, non-lactating females between 18-70 years old

Summary:

This study focuses on patients who have liver cirrhosis as a result of nonalcoholic steatohepatitis (NASH). The study will evaluate an experimental drug called selonsertib for the treatment of advanced fibrosis of the liver due to NASH. NASH is a disease that results when fat accumulates in the liver; the body’s immune system may respond to the fat by attacking liver cells. Selonsertib is being developed to reduce inflammation and fibrosis in the liver. Researchers will assess the effects, safety and tolerability of selonsertib , as well as whether it can reduce fibrosis and associated complications in patients with cirrhosis and fibrosis due to NASH.

Condition:

Nonalcoholic fatty liver disease, cirrhosis, hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • History of nonalcoholic fatty liver disease with or without cirrhosis or hepatocellular carcinoma diagnosed within the last 6 months

Summary:

This study focuses on patients from Cedars-Sinai and Veteran's Administration Greater Los Angeles Healthcare System who have liver disease. Researchers believe that differences in gut bacteria and the products of these bacteria, together with other factors such as diet and body composition, may help to explain why some people with nonalcoholic liver disease progress to liver cirrhosis or cancer. In this study, researchers will evaluate the differences between biomarkers measured in participants' specimens, clinical data, and questionnaire data to learn more about why nonalcoholic fatty liver disease progresses in some people.

Pancreatic & Biliary Diseases

Condition:

Biliary disease, pancreas disease, interventional endoscopy

Key Inclusion Criteria:

  • Pediatric patients who are less than 18 years old and identified as needing ERCP

Summary:

This study focuses on pediatric patients who have been identified as needing an endoscopic procedure called endoscopic retrograde cholangiopancreatography (ERCP). The purpose of the study is to gain knowledge about ERCP, which is used to diagnose and treat problems in the bile and pancreas. During this procedure, a narrow, flexible tube (endoscope) that has a video camera is utilized. Participants will be asked for permission to review medical records; additional procedures or clinic visits are not required to take part in the study. Researchers aim to learn more about the indications and safety of ERCP in pediatric patients to improve treatment and create specific guidelines for using this procedure in children.

Condition:

Gastrointestinal mucosal/submucosal disease

Key Inclusion Criteria:

  • At least 18 years old
  • Scheduled to undergo ESD as part of standard-of-care treatment

Summary:

This study focuses on individuals who have a mass or nodule anywhere in the esophagus, stomach or intestines and who have been scheduled for an endoscopic submucosal dissection (ESD) procedure. The purpose of the study is to collect clinical information about individuals who undergo ESD at Cedars-Sinai. ESD is an advanced endoscopic procedure used to treat abnormalities on the wall of the gastrointestinal tract (esophagus, stomach or intestine).

By using ESD, the need for open surgery is avoided, and large areas of affected tissue can be removed in one piece while protecting the healthy areas. Researchers believe it is important to obtain information on how patients respond to ESD treatment so that it can be used in large patient populations who need endoscopic treatment for gastrointestinal abnormalities.

Condition:

Pancreatic adenocarcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • Confirmed locally advanced pancreatic adenocarcinoma
  • Has at least one lesion with a diameter of at least 1.5 cm but no more than 6 cm within 6 weeks of screening

Summary:

This study focuses on patients who have pancreatic cancer that cannot be removed with surgery and who have already received standard of care treatment (including IV chemotherapy). The purpose of the study is to determine whether the use of an investigational drug called NanoPac helps kill cancer cells in patients with pancreatic cancer. Researchers also aim to identify the dose of NanoPac that is best tolerated and causes the least side effects when injected directly into the tumor in the pancreas.

NanoPac is made of very small particles of another drug called paclitaxel, which is a chemotherapy drug approved by the U.S. Food and Drug Administration for other types of cancer. The use of Nanopac in this study is investigational.

Condition:

Pancreatic diseases

Key Inclusion Criteria:

  • Patient who is or will be scheduled for a blood draw, tissue biopsy, and/or biofluid collection at Cedars-Sinai for clinical diagnostic purposes and
  • Adult patient with pancreatic disease seen at Cedars-Sinai under the care of a Panc -Bank study investigator who is the patient's treating physician

Summary:

The purpose of the Pancreatic Biomarker Bank (" Panc -Bank") is to identify biomarkers that influence an individual's risk of developing pancreatic diseases. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. Through the Panc -Bank, researchers also aim to discover new tests and treatments for pancreatic diseases, as well as further their understanding of these diseases.

The Panc Bank will collect patients' blood, tissue, and biofluid samples to be used for future research; these materials will be studied together with clinical information from medical records.

Condition:

Diagnostic, biliary hilar obstruction, percutaneous transhepatic biliary drainage, endoscopic retrograde cholangiopancreatography

Key Inclusion Criteria:

  • Patient with cholestasis (decrease in bile flow) due to suspected malignant hilar obstruction (tumors)
  • Over 40 years old
  • Evidence of a biliary hilar stricture (narrowing of bile duct) or intrahepatic but no extrahepatic biliary ductal dilation (duct dilation within the liver but not outside the liver)

Summary:

This study focuses on individuals who are over 40 years old and who have biliary hilar obstruction or intrahepatic biliary ductal dilation (a sign of a blockage in the biliary tree). The liver produces bile, a fluid that helps the body digest fats and transmits it to the small intestine through the “biliary tree.” The purpose of the study is to compare two methods of biliary drainage when malignant hilar obstruction (blockage) is suspected. The methods are called percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiography (ERC).

Researchers aim to determine which of these two methods for collecting information about the blockage and providing relief (drainage) for the blockage is more effective. Researchers will also compare the safety, ease of procedure , and overall improvement in patient outcomes. Participants will be randomly assigned to undergo either the PTBD or ERC procedure.

Condition

Primary biliary cholangitis

Key Inclusion Criteria

  • 18-75 years old
  • Primary biliary cholangitis by at least two of the following criteria:
    • History of alkaline phosphatase above upper limit of normal (ULN) for at least 6 months
    • Positive anti-mitochondrial antibodies titers
    • Documented liver biopsy result consistent with primary biliary cholangitis (with no cirrhosis)

Summary

The purpose of this study is to evaluate whether an investigational drug called EDP-305 is safe and effective for individuals with primary biliary cholangitis (PBC), a chronic disease of the liver, in patients with or without an inadequate response to ursodiol therapy. Researchers also aim to determine the dose of study drug that works best. The study will compare the effects of EDP-305 against the effects of a placebo (inactive substance). Samples for biomarkers will also be collected. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease. Biomarkers can be helpful in evaluating the effectiveness and safety of a medicine. Participants will be randomly assigned to receive EDP-305 or placebo.

Condition:

Diabetes, pancreatic cancer, pancreatic diseases

Key Inclusion Criteria:

  • At least 40 years old; less than 85 years old
  • Must have a diagnosis of one of the following:
    • New onset diabetes in subjects with pancreatic cancer (PDAC)
    • New onset diabetes in subjects with chronic pancreatitis
    • New onset diabetes in subjects without pancreatic disease 
    • Long-standing Type 2 diabetes without pancreatic disease
    • Long-standing diabetes in subjects with PDAC
    • Long-standing diabetes subjects with chronic pancreatitis
    • Non-diabetic subjects with PDAC
    • Non-diabetic subjects with chronic pancreatitis
    • Non-diabetic control subjects without pancreatic disease

Summary:

This study focuses on patients who have chronic pancreatitis, pancreatic cancer, or no known pancreas disease. It is now recognized that a small portion of the population with diabetes have an underlying problem with their pancreas, such as chronic pancreatitis (when the pancreas is swollen and irritated all the time and affected by scarring) or pancreatic cancer, as the cause of their diabetes. Currently, there is no test to identify the small number of patients who have diabetes caused by a primary problem with their pancreas. The purpose of this study is to develop a blood test to distinguish various causes of diabetes. To this end, researchers will enroll a range of patients; most have developed diabetes within the last 3 years, but the study will also enroll a small number of patients with long-term diabetes and normal blood sugars for comparison. Participants will be asked to complete a questionnaire regarding their personal and family history, and a series of blood samples will be collected prior to and for 2 hours following consumption of a liquid nutritional supplement called Boost. 

Condition:

Pancreatitis

Key Inclusion Criteria

  • Must be between 18-75 years old at the time of enrollment

GREEN GROUP I: No Pancreas Disease Controls

  • No personal history or symptoms of pancreatic disease

GREEN GROUP II: Chronic Upper Abdominal Pain of Suspected Pancreatic Origin

  • Referred to a pancreas or GI clinic or admitted to the hospital for evaluation unexplained upper abdominal pain of at least 3 months in duration

YELLOW GROUP I: Indeterminate Chronic Pancreatitis (CP) with no history of Acute Pancreatitis

  • Referred to a pancreas or GI clinic or admitted to the hospital for evaluation of unexplained upper abdominal pain of at least 3 months in duration

YELLOW GROUP II: Acute Pancreatitis (AP)

  • History of 1 documented attack of AP in the preceding 18 months

YELLOW GROUP III: Recurrent Acute Pancreatitis (RAP)

  • 2 or more documented attacks of AP separated by at least 1 month

RED GROUP: Definite Chronic Pancreatitis

  • Presence of unequivocal (definite) CP and/or parenchymal and/or ductal calcifications 

Summary:

The purpose of this study is to learn about chronic pancreatitis and discover new ways to detect, treat and help prevent the disease. The study aims to determine how the diagnosis can be made earlier, why and how the disease progresses, and what genetic factors may affect the chances of developing chronic pancreatitis. Researchers also aim to learn about the natural history of chronic pancreatitis (what happens over a long period of time).

Chronic pancreatitis occurs when the pancreas is affected by inflammation and scarring. Since treatment options for advanced (end-stage) chronic pancreatitis are limited, patients with early-stage chronic pancreatitis or those at high risk of developing chronic pancreatitis are ideally suited for interventions to prevent the development of end-stage pancreatitis and its associated complications. This study aims to provide the most accurate and reliable estimates to date on disease progression and clinical events involving chronic pancreatitis. Participants will be asked to complete questionnaires and provide specimen samples, among other study procedures. Additionally, the participant’s physician and research coordinator will complete a case report form about the participant’s pancreatic history, symptoms and treatment.

Inflammatory Bowel Disease

Condition:

Inflammatory bowel disease

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosis of Crohn’s disease, ulcerative colitis or IBD undetermined
  • Accept conditions of informed consent
  • Affiliated with a participating IBD care site

Summary:

This study is designed as a program to collect health information from adults with inflammatory bowel disease (IBD) to better understand the disease and improve the quality of care for individuals living with IBD. The program will focus on a new way to manage IBD care, referred to as a dashboard, which will allow for more informed and productive communication between patients and providers.

Health information will be collected for quality improvement initiatives and research from three sources: medical records at the IBD Care Center, information that the provider enters into the dashboard, and information that the patient enters into the dashboard. Data will be maintained in a secure database.

Condition:

Inflammatory bowel disease

Key Inclusion Criteria:

  • Diagnosis of IBD
  • Family members of patients participating in the M.I.R.I.A.D. Biobank
  • Control subjects without IBD

Summary:

The purpose of the M.I.R.I.A.D. Biobank is to advance the understanding of inflammatory bowel diseases (IBD) and other inflammatory disorders. The Biobank collects specimens for immediate use in research studies and maintains specimens for future use. It also gathers information about donated samples from participants' medical records. Specimens and health information are used in M.I.R.I.A.D. Biobank-supported investigations to improve the diagnosis and treatment of disease. Current and future uses of specimens may include genome sequencing, stem cell research and/or creation of cell lines.

Condition:

Ulcerative Colitis

Key Inclusion Criteria:

  • 18-75 years old
  • Documented diagnosis of ulcerative colitis of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge
  • Moderately to severely active ulcerative colitis

Summary:

This study focuses on patients diagnosed with ulcerative colitis, an inflammatory disease of the large intestines. The purpose of the study is to determine whether an investigational drug called filgotinib is effective and safe for the treatment of moderate to severe ulcerative colitis. Researchers will compare different doses of filgotinib to a placebo (inactive substance) to learn which is more effective; participants will be randomly assigned to a study group. Biomarker testing will also be conducted. Biological markers (biomarkers) are substances in the body that can offer clues as to how the drug is affecting the body and a disease.

Condition:

Crohn's Disease

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosis of Crohn’s disease
  • In clinical remission

Summary:

This study focuses on patients who have well-controlled Crohn’s disease and low levels of Vitamin D. The purpose of the study is to determine the best strategy to maintain adequate Vitamin D levels in patients with Crohn’s disease who are in clinical remission. Although vitamin supplementation (consuming vitamins in addition to the nutrients in food eaten) is not approved by the Food and Drug Administration as treatment, it is routinely prescribed by physicians for support of bone health and nutrition. Studies have also found that low vitamin D levels are associated with poorer quality of life. Researchers will compare the effects of Vitamin D3 against the effects of a placebo (inactive substance); participants will be randomly assigned to a study group.

Condition:

Ulcerative Colitis

Key Inclusion Criteria:

  • 18-75 years old
  • Documented diagnosis of ulcerative colitis of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge
  • Moderately to severely active ulcerative colitis

Summary:

This study focuses on patients diagnosed with ulcerative colitis, an inflammatory disease of the large intestines. The purpose of the study is to determine whether an investigational drug called filgotinib is effective and safe for the treatment of moderate to severe ulcerative colitis. Researchers will compare different doses of filgotinib to a placebo (inactive substance) to learn which is more effective; participants will be randomly assigned to a study group. Biomarker testing will also be conducted. Biological markers (biomarkers) are substances in the body that can offer clues as to how the drug is affecting the body and a disease.

Condition:

Gastrointestinal symptoms

Key Inclusion Criteria:

  • At least 18 years old
  • New patient visit with a dietician at Cedars-Sinai or University of Michigan
  • Access to modern device supporting iOS (tablets, iPads, iPhones, and Android) and internet access

Summary:

This study focuses on patients who are scheduled to see a dietician at a future appointment as part of routine clinical care. The purpose of the study is to evaluate the impact of the My Nutritional Health Application. This mobile app allows individuals to maintain a food diary and track gastrointestinal (GI) symptoms through the Food and Symptoms Tracker (FAST). Researchers aim to examine the relationship between participants’ GI symptoms and food. Once participants have downloaded the app, they will be prompted to answer questions related to food intake and mental or physical symptoms that may suggest food intolerance. A member of the study team will reach out to participants to assist with any technical difficulties or to answer questions.

Condition:

Ulcerative colitis, Crohn's disease

Key Inclusion Criteria

  • Weighs ≥10 kg
  • 2-17 years old, with moderately to severely active UC or CD diagnosed at least 3 months before screening

Summary:

This study focuses on children diagnosed with either Crohn’s disease (CD) or ulcerative colitis (UC) and who are between the ages of 2 and 17. The purpose of the study is to examine how a drug called vedolizumab is processed by the body in these children. Researchers also aim to evaluate whether vedolizumab is safe and effective for the treatment of UC and CD in children and to determine which dose may be best. Vedolizumab belongs to a group of proteins called antibodies, which help to reduce inflammation that can cause the symptoms in CD and UC. The use of vedolizumab in this study is investigational.

Condition:

Ulcerative colitis, Crohn's disease

Key Inclusion Criteria

  • Male or female with UC or CD between 2-17 years old at the time of group assignment for study MLN0002-2003
  • Completed study MLN0002-2003 and at week 22 of the study, achieved clinical response

Summary:

This study focuses on patients who have previously participated in the MLN0002-2003 study (A Phase II, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease). Researchers will evaluate the long-term safety of a drug called vedolizumab in children who have ulcerative colitis (UC) or Crohn's disease (CD).

Small Bowel Disease and Nutrition

Condition:

Bacterial overgrowth

Key Inclusion Criteria:

  • Between 18-65 years old
  • Must be referred for a double balloon enteroscopy as standard of care for obscure gastrointestinal bleed

Summary:

The purpose of this study is to determine normal bacterial counts in the small bowel of healthy (non-irritable bowel syndrome) individuals. Previous studies have shown that that bacterial overgrowth may be the cause of irritable bowel syndrome (IBS). Patients with IBS have been shown to have abnormal lactulose breath tests; however, breath testing is an indirect measure of bacterial overgrowth. Because the standard methods for diagnosing IBS are problematic, researchers aim to study bacterial counts in the small intestines of non-IBS patients through real-time polymerase chain reaction (PCR). PCR is a technique through which a single or few copies of a piece of DNA can be magnified.

Condition:

Ulcerative Colitis

Key Inclusion Criteria:

  • 18-75 years old
  • Documented diagnosis of ulcerative colitis of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge
  • Moderately to severely active ulcerative colitis

Summary:

This study focuses on patients diagnosed with ulcerative colitis, an inflammatory disease of the large intestines. The purpose of the study is to determine whether an investigational drug called filgotinib is effective and safe for the treatment of moderate to severe ulcerative colitis. Researchers will compare different doses of filgotinib to a placebo (inactive substance) to learn which is more effective; participants will be randomly assigned to a study group. Biomarker testing will also be conducted. Biological markers (biomarkers) are substances in the body that can offer clues as to how the drug is affecting the body and a disease.

Condition:

Crohn's Disease

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosis of Crohn’s disease
  • In clinical remission

Summary:

This study focuses on patients who have well-controlled Crohn’s disease and low levels of Vitamin D. The purpose of the study is to determine the best strategy to maintain adequate Vitamin D levels in patients with Crohn’s disease who are in clinical remission. Although vitamin supplementation (consuming vitamins in addition to the nutrients in food eaten) is not approved by the Food and Drug Administration as treatment, it is routinely prescribed by physicians for support of bone health and nutrition. Studies have also found that low vitamin D levels are associated with poorer quality of life. Researchers will compare the effects of Vitamin D3 against the effects of a placebo (inactive substance); participants will be randomly assigned to a study group.

Condition:

Gastrointestinal disorders

Inclusion Criteria:

  • 18-85 years old
  • Undergoing oral double balloon endoscopy or esophagogastroduodenoscopy
  • Must not have had any colon prep

Summary:

This study focuses on patients who are undergoing either an oral double balloon endoscopy procedure or an esophagogastroduodenoscopy procedure as part of their clinical care. The purpose of the study is to understand how microorganisms in the gut affect individuals and how they may contribute to gut-related human diseases. Researchers aim to examine gut microorganisms in the small intestine. Specifically, researchers would like to examine how various gut microbes may be affected by genetic makeup and affect which genes are turned on or off in various parts of the gut. The results will help researchers to better understand how gut microorganisms may contribute to gut-related diseases.

Financial disclosure: Mark Pimentel, MD, may receive may receive future royalty income in the future based on a patent, or copyright, or other intellectual property directly related to this research.

Condition:

Gastrointestinal symptoms

Key Inclusion Criteria:

  • At least 18 years old
  • New patient visit with a dietician at Cedars-Sinai or University of Michigan
  • Access to modern device supporting iOS (tablets, iPads, iPhones, and Android) and internet access

Summary:

This study focuses on patients who are scheduled to see a dietician at a future appointment as part of routine clinical care. The purpose of the study is to evaluate the impact of the My Nutritional Health Application. This mobile app allows individuals to maintain a food diary and track gastrointestinal (GI) symptoms through the Food and Symptoms Tracker (FAST). Researchers aim to examine the relationship between participants’ GI symptoms and food. Once participants have downloaded the app, they will be prompted to answer questions related to food intake and mental or physical symptoms that may suggest food intolerance. A member of the study team will reach out to participants to assist with any technical difficulties or to answer questions.

Hepatology

Condition:

Liver cirrhosis, hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosed with liver cirrhosis
  • Requires an upper gastrointestinal endoscopy by a Cedars-Sinai, UCLA and Veterans Affairs Greater Los Angeles Healthcare System gastroenterologist for standard of care

Summary:

This study focuses on patients who have liver cirrhosis. There is growing evidence that individuals with cirrhosis have changes in their gastrointestinal systems, including changes to the types of microbes that make up their gastrointestinal tract. Changes to these microbes may lead to inflammation (swelling) and other issues related to a worsening of liver disease. In this study, researchers aim to measure and evaluate changes in the intestines and throughout the entire body of patients with liver cirrhosis by collecting tissue and fluid samples from the small intestine (duodenum), as well as blood samples. In order to investigate the lifestyle factors that might be associated with these changes, participants will also be asked to complete questionnaires about dietary intake, lifestyle habits, medications and medical history. Patients will be followed over time to study changes in their disease.

Condition:

Nonalcoholic fatty liver disease, cirrhosis, hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • History of nonalcoholic fatty liver disease with or without cirrhosis or hepatocellular carcinoma diagnosed within the last 6 months

Summary:

This study focuses on patients from Cedars-Sinai and Veteran's Administration Greater Los Angeles Healthcare System who have liver disease. Researchers believe that differences in gut bacteria and the products of these bacteria, together with other factors such as diet and body composition, may help to explain why some people with nonalcoholic liver disease progress to liver cirrhosis or cancer. In this study, researchers will evaluate the differences between biomarkers measured in participants' specimens, clinical data, and questionnaire data to learn more about why nonalcoholic fatty liver disease progresses in some people.

Condition:

Hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosis of liver cirrhosis
  • Diagnosis of hepatocellular carcinoma

Summary:

This study focuses on individuals who have been diagnosed with an early-stage hepatocellular carcinoma (HCC) and who have been treated with therapies targeting the liver. The purpose of the study is to examine the effects that an investigational drug called pravastatin has on the time it takes for HCC to occur again in patients with early-stage HCC. Researchers believe that pravastatin, in combination with therapies targeting the liver, may delay or protect against HCC occurring again.

Pravastatin is a type of statin that is approved by the U.S. Food and Drug Administration (FDA) for various conditions. However, it is not approved by the FDA to delay or protect against HCC occurring again. The study will compare the effects of pravastatin against the effects of a placebo (inactive substance). Participants will be randomly assigned to receive either pravastatin or a placebo.

Condition:

Liver cirrhosis

Summary:

This study focuses on patients with liver cirrhosis (scarring of the liver which results in abnormal liver function). The purpose of the study is to compare the safety and effects of simvastatin in individuals with liver cirrhosis who are at an increased risk for liver cancer. Participants will receive either simvastatin or placebo (inactive substance). Simvastatin is approved by the U.S. Food and Drug Administration for various conditions, but its use in this study is investigational. Previous studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. Researchers believe that this anti-inflammatory effect of simvastatin may delay disease progression to cancer in patients with liver cirrhosis.

Condition:

Primary biliary cirrhosis

Key Inclusion Criteria:

  • Definite or probable PBC diagnosis
  • At least 18 years old
  • A mean total bilirubin greater than upper limit of normal (ULN) and ≤3 X ULN or an alkaline phosphatase >5 X ULN

Summary:

This study focuses on patients who have primary biliary cholangitis (PBC), a progressive liver disease caused by a buildup of bile that results in damage to the bile ducts that drain bile from the liver. The purpose of the study is to evaluate the investigational use of a drug called obeticholic acid (also known as OCA) and its effect on PBC when given with ursodeoxycholic acid. OCA is a man-made version of a natural compound produced in the liver called bile acid. Researchers aim to determine the safety and effectiveness of OCA in delaying specific medical conditions or health-related issues that can occur in patients with PBC.

The current standard of care for adults with PBC is ursodeoxycholic acid for an indefinite length of time. In this study, researchers will compare OCA to the standard treatment to learn which is more effective.

GI Motility

Condition:

Gastroesophageal reflux disease and irritable bowel syndrome

Inclusion Criteria:

  • Patients at the Cedars-Sinai GI Motility Program referred for an esophageal manometry and/or pH test

Summary:

This purpose of this study is to determine whether patients with irritable bowel syndrome (IBS) will be more likely to have a lower sphincter resting pressure than those who do not on esophageal manometry (a test used to identify problems with the esophagus). Researchers have recently found an overlap between patients with gastroesophageal reflux disease (GERD), a condition known to include heartburn, and IBS. Data from this study will be used to look for risk factors for GERD and other motility disturbances of the esophagus. Participants will be asked to complete a questionnaire and provide a breath sample.

Condition:

Gastrointestinal symptoms

Key Inclusion Criteria:

  • At least 18 years old
  • New patient visit with a dietician at Cedars-Sinai or University of Michigan
  • Access to modern device supporting iOS (tablets, iPads, iPhones, and Android) and internet access

Summary:

This study focuses on patients who are scheduled to see a dietician at a future appointment as part of routine clinical care. The purpose of the study is to evaluate the impact of the My Nutritional Health Application. This mobile app allows individuals to maintain a food diary and track gastrointestinal (GI) symptoms through the Food and Symptoms Tracker (FAST). Researchers aim to examine the relationship between participants’ GI symptoms and food. Once participants have downloaded the app, they will be prompted to answer questions related to food intake and mental or physical symptoms that may suggest food intolerance. A member of the study team will reach out to participants to assist with any technical difficulties or to answer questions.

Condition:

Irritable bowel syndrome

Key Inclusion Criteria (IBS participants):

  • Must meet Rome II criteria
    • At least 12 weeks of abdominal discomfort or pain that has two of three features:
      • Relieved with defecation and/or
      • Onset associated with a change in frequency of stool and/or
      • Onset associated with a change in form (appearance) of stool

Summary:

The purpose of this study is to understand the causes of irritable bowel syndrome (IBS) by looking at both genetic and immunologic mechanisms. Examination of DNA will enable researchers to understand which gene(s) contributes to the development of IBS. In this study, researchers aim to create a bank of blood for future genetic analyses to identify specific genes responsible for IBS development. They also aim to identify possible tests, such as looking for antibodies (which act as an immune defense) to food poisoning toxins, to help diagnose and evaluate the likelihood that they lead to IBS.

Condition:

Colonic inertia

Inclusion Criteria:

  • Patients with colonic inertia
  • At least 18 years old

Summary:

The purpose of this pilot study is to identify the causes of a condition called colonic inertia, which involves severe constipation. Often, colonic inertia can only be treated by surgery to remove almost the entire colon (large bowel). Researchers aim to determine whether colonic inertia can be caused by changes in the types of microbes (bugs) that are present in the colon, or possibly by a toxin (poison) produced by particular microbes. Understanding the causes of colonic inertia is the first step in developing future treatments. Participants will be asked to provide stool samples when they are able to, as well as complete a questionnaire.

Esophageal Disorders

Condition:

Gastroesophageal reflux disease and irritable bowel syndrome

Inclusion Criteria:

  • Patients at the Cedars-Sinai GI Motility Program referred for an esophageal manometry and/or pH test

Summary:

This purpose of this study is to determine whether patients with irritable bowel syndrome (IBS) will be more likely to have a lower sphincter resting pressure than those who do not on esophageal manometry (a test used to identify problems with the esophagus). Researchers have recently found an overlap between patients with gastroesophageal reflux disease (GERD), a condition known to include heartburn, and IBS. Data from this study will be used to look for risk factors for GERD and other motility disturbances of the esophagus. Participants will be asked to complete a questionnaire and provide a breath sample.

Gastrointestinal Oncology

Condition:

Hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • Diagnosis of liver cirrhosis
  • Diagnosis of hepatocellular carcinoma

Summary:

This study focuses on individuals who have been diagnosed with an early-stage hepatocellular carcinoma (HCC) and who have been treated with therapies targeting the liver. The purpose of the study is to examine the effects that an investigational drug called pravastatin has on the time it takes for HCC to occur again in patients with early-stage HCC. Researchers believe that pravastatin, in combination with therapies targeting the liver, may delay or protect against HCC occurring again.

Pravastatin is a type of statin that is approved by the U.S. Food and Drug Administration (FDA) for various conditions. However, it is not approved by the FDA to delay or protect against HCC occurring again. The study will compare the effects of pravastatin against the effects of a placebo (inactive substance). Participants will be randomly assigned to receive either pravastatin or a placebo.

Condition:

Liver cirrhosis

Summary:

This study focuses on patients with liver cirrhosis (scarring of the liver which results in abnormal liver function). The purpose of the study is to compare the safety and effects of simvastatin in individuals with liver cirrhosis who are at an increased risk for liver cancer. Participants will receive either simvastatin or placebo (inactive substance). Simvastatin is approved by the U.S. Food and Drug Administration for various conditions, but its use in this study is investigational. Previous studies show that simvastatin lowers the risk of heart disease not only by decreasing cholesterol, but also by decreasing inflammation. Researchers believe that this anti-inflammatory effect of simvastatin may delay disease progression to cancer in patients with liver cirrhosis.