GI Motility Clinical Trials

As a patient at Cedars-Sinai, you will have access to the latest clinical trials and research for GI motility. Backed by a respected team of specialists and researchers, our clinical trials aim to further the advancement of diagnosing and treating your GI motility condition.

Questions? See the Clinical Trials FAQs.

Condition:

Colonic Inertia

Key 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.

Condition:

Irritable bowel syndrome, constipation

Key Inclusion Criteria

  • 18-65 years old
  • IBS-C symptoms for at least 6 months before diagnosis
  • Average score of ≥3.0 for daily abdominal pain at its worst (11-point numerical rating scale) during and up to 17 days before assignment to treatment group

Summary:

The purpose of this study is to evaluate whether an experimental drug called SYN-010 is effective in patients who have irritable bowel syndrome with constipation (IBS-C). The study aims to determine whether SYN-010 works better than placebo (inactive substance) to improve symptoms of IBS-C.

SYN-010 is a modified-release, oral formulation of a drug called lovastatin. Lovastatin, in its unmodified form, is approved by the U.S. Food and Drug Administration (FDA) for other conditions, but it is not approved by the FDA for the treatment of IBS-C. Researchers will examine the effects of two different doses of SYN-010 on clinical symptoms of IBS-C compared with placebo. Participants will be randomly assigned to one of three treatment groups: Group 1 will receive the lower dose of SYN-010; Group 2 will receive the higher dose of SYN-010; and Group 3 will receive the placebo.

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:

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:

Gastroesophageal reflux disease and irritable bowel syndrome

Key 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.