Nutrition & Integrative Inflammatory Bowel Disease
The Nutrition and Integrative Inflammatory Bowel Disease Program was established to formally explore the role of dietary and alternative strategies in inflammatory bowel disease (IBD). The goal of the program is to optimize quality of life and potentially minimize symptoms and disease activity through the integration of specific nutritional and other alternative approaches with established medical therapies. The program is targeted to individuals with Crohn's disease, ulcerative colitis, lymphocytic and collagenous colitis, and IBD-associated small intestinal bacterial overgrowth.
What Makes Us Unique
- Program combining the insights of a dietitian and an IBD-focused gastroenterologist
- Customized dietary counseling
- One of only a few such integrative IBD practices in the world
- Opportunities to participate in our IBD Nutrition and Integrative Registry
- Respect for each patient’s existing relationship with his or her regular gastroenterologist, who will continue to serve as the primary IBD care provider
- How to address existing and potential nutritional deficiencies.
- How to incorporate dietary, lifestyle and other integrative strategies as adjunctive modalities with the goal of optimizing health.
- The role for macronutrient and micronutrient supplementation.
- Potential role of diet, supplements and/or alternative modalities on recurrent extra-intestinal manifestations of IBD, such as joint involvement and mouth ulcers.
For physician-to-physician consultations, give us a call.
Frequently Asked Questions
Dermot McGovern, MD, Stephan R. Targan, MD, Andrew Ippoliti, MD, Eric Vasiliauskas, MD, Phillip Fleshner, MD, Gil Melmed, MD, David Shih, MD, and Debbie Dutridge, MA are conducting a research study.
This study is sponsored by National Institutes of Health (NIH). The study sponsor provides funding to cover some or all of the costs of conducting this research.
You are being asked to take part in this study because either you or at least one member of your family has inflammatory bowel disease (IBD) (ulcerative colitis or Crohn's disease). To get appropriate control information, we are also inviting people who do not have IBD to participate in this study as normal controls.
Research studies include only people who choose to take part. Please take your time to make your decision and discuss it with your friends and family. Remember that your participation is completely voluntary.
This research is being done because little is known about which genes cause some individuals to be at risk for developing IBD. The purpose of this study is to identify genes that predispose some individuals to IBD. Once these genes have been found, we can then identify the causes of IBD and develop ways to prevent its onset.
An invitation to participate in genetic testing does not necessarily indicate that you or other family members suffer from a particular disorder or are genetically at risk for that disorder.
Cedars-Sinai investigators must satisfy federal requirements for identifying and managing potential conflicts of interest before a research study can be approved. The purpose of these requirements is to ensure that the design, conduct and reporting of the research will not be biased by any conflicting interests. If at any time you have specific questions about the financial arrangements or other potential conflicts for this study, please feel free to contact any of the individuals listed furthere below in this FAQ.
The investigator of this research does not have any financial interest in the sponsor or in the study; this means that the investigator will not be financially affected by the results of the study (positive or negative). However, Cedars-Sinai Medical Center and the investigators will be reimbursed by the Sponsor for the work that they and the medical staff have to do as part of this study, and for the use of the site's facilities.
The person inviting you to participate in this research may also be your treating doctor. In such cases, the doctor has an interest in both your care and promoting the successful conduct of this research. Sometimes these two interests may cause conflict. You can choose not to participate in the research and still receive treatment from your doctor. If you wish, you may also request to speak to another doctor who is not a member of the research team about your options.
Currently we have studied over 10,000 people. We plan to study an additional 500 per year for the next 5 years. The reason we need to study such a large number of people is because IBD is a complex disease. Different genes may cause a similar clinical disease or said another way, different causes can lead to IBD. In order to identify each of these genes, we will need to have enough people in each clinical subgroup (such as people affected with ulcerative colitis who also express certain immune proteins in the blood known as antineutrophil cytoplasmic antibodies).
You and other family members will be asked to have a blood sample drawn (~3 tablespoons/40mL), either here at Cedars-Sinai, in your home (if you live in the Los Angeles area) or at your treating doctor's office or medical laboratory. Blood samples drawn outside of Los Angeles area will need to be sent to us via express mail within two days. The blood will be used for genetic-testing and immunologic antibody determination. Part of this blood will be used to establish a long-term cell line. In the unlikely event that your cell line does not transform, we would like to draw an additional ~1½ tablespoons (20mL) of blood, if possible. The study coordinator will contact you to make arrangements.
We will ask you all to complete a questionnaire in order to draw a family tree based on your family’s medical history. We think it should take approximately one hour to complete the questionnaire. You will be asked to do the questionnaire once. If you feel uncomfortable answering any of the questions that we ask you, you are not required to answer them and the researcher will not insist that you respond. The questionnaire will ask you to provide information that identifies you by noting information such as your name, Social Security Number, medical record number, address, and more.
You are being asked for your authorization to allow the research team to review medical records and also to gather or create new health information about you, from any of the following sources:
- Doctor/clinic records
- Hospital/medical records; and
- Pathology reports
You may be asked to sign a release medical records form that will then be sent to the hospital or doctors who have cared for you. In addition, any medical records belonging to your doctor may be reviewed and used as part of this research study. Donation of blood plus health information together helps researchers to discover relationships between health history and specific characteristics of Inflammatory Bowel Disease.
DNA is the substance in our cells, which contains information we inherited from our parents. Your DNA contains genes, which predict things like physical characteristics (eye color, hair color, height, etc.) and may also be a factor in whether you develop or are at risk of developing certain illnesses or disorders. Your DNA will be tested to see if we can find the gene or genes that lead to the development of IBD. Your blood sample will be used to isolate DNA for genetic testing.
Part of your blood sample will also be used to grow a long term cell line. This immortalized cell line, called a lymphoblastoid cell line, will be stored in the Tissue Culture laboratory at Cedars-Sinai Medical Center and will be available for research by Dr. McGovern, both now and in the future. This also allows us to perform many tests without having to ask you for additional blood samples.
Part of your blood sample may be used for Immunologic Studies. Your blood sample may be used to observe important biochemical markers (proteins found in the blood) in the blood of patients with IBD throughout the course of their disease – active and in remission. Observing these markers will help to better understand the inflammatory process associated with IBD during active disease and remission. Serum from blood samples may be banked (frozen and stored) in the IBD Research Repository for antibody testing in current and future research.
Genetic variations are found in people everywhere. Some variations can directly cause diseases to occur, but all of us carry variations that do not cause disease. Testing large numbers of these non-disease variations makes it easier to find genes that affect diseases. This type of testing is called Genome Wide Association Studies (GWAS). The pattern of variations is unique to individuals, like a fingerprint. This is useful for locating genes in many conditions, not just Inflammatory Bowel Disease.
To make the best possible use of GWAS results, the National Institutes of Health (NIH) policy requires researchers to share the information from GWAS studies with other researchers. Since this study is funded by the NIH, this policy applies. The goal of the policy is to facilitate broad and consistent access to NIH-supported GWAS data to speed the translation of basic genetic research into therapies, products, and procedures that benefit the public health. More information about this policy is available at http://grants.nih.gov/grants/gwas/. Other organizations have also developed similar policies to encourage data sharing.
Your direct participation in this research will require one visit that should take approximately 30 minutes to 1 hour.
In many genetic studies, testing of the DNA may go on for very long periods of time. This is true because we are continually finding new genes that may be involved in IBD. Therefore, while your direct participation in this study will be done once you have completed the procedures/visits described above, the DNA isolated from your blood may continue to be studied for many years. In addition, we may analyze your DNA sample as part of other research activities or share portions of your sample and/or data with other researchers working in other institutions.
Cells, blood, or other specimens removed from you during the course of this study may be valuable for scientific, research or teaching purposes or for the development of a new medical product. By agreeing to participate in this research, you authorize Cedars-Sinai and members of its staff to use your cells, blood or other specimens for these purposes.
Any tissues you have donated which are used in research may result in new tests, discoveries, or products. In some cases, these may be valuable and may be developed and owned by the investigators, Cedars-Sinai Medical Center, or the study sponsor. You no longer own your tissue after it has been donated and therefore you will not share in any revenues from these products, tests, or discoveries should they occur.
Cedars-Sinai will maintain these routine samples indefinitely or until the samples are exhausted. These samples are unavailable for clinical (diagnostic) purposes. Therefore, any future diagnostic testing as a result of this or other research must be performed using a new sample. In the event this research project results in a product, which could be sold commercially, Cedars-Sinai and its collaborators will assert the exclusive right to any revenue from the sale of such a product.
As described above, data collected about you (with identifying information removed) will be submitted to the GWAS database. Once submitted, this data will be controlled by the NIH. The NIH is committed to protecting the confidentiality of all the information it receives, but will also comply with relevant laws which might include Freedom of Information Act (FOIA) requests for non- identifiable information.
Neither you nor your physician will be able to obtain the results of this research because it is still preliminary and we do not yet know what the results of the tests might mean. However, we will provide you with any published material pertaining to the general results of this research upon request. At the end of this consent document, you will be given an opportunity to indicate whether you wish to receive any published material pertaining to the general results of this research.
While on this study, you may experience certain side effects. There also may be other side effects that we cannot predict.
Blood drawing may cause some pain and carries a small risk of bleeding, bruising, or infection at the puncture site. There is also a small risk of fainting.
It is possible that this study will identify information about you that was previously unknown (such as disease status or risk). Such incidental findings, if any, will not be shared with anyone related to you unless the incidental finding regards an inherited risk for a disease known at the time of testing to be likely to cause premature death if untreated. Should such life-threatening results be uncovered through these genetic research studies and if they are directly applicable to you or to your minor children, you will be notified via certified mail to contact Dermot McGovern, MD at Cedars-Sinai Medical Center (CSMC). Notification will be sent to the last address you provided to us. The CSMC staff will not release these specific research findings over the telephone or in the mail. Dermot McGovern, MD will arrange for you to meet with him and/or a genetic counselor or other appropriate health care provider either at CSMC or another medical institution near your residence to review the research information.
There is a risk for discrimination against individuals who are at-risk for a medical disorder or have a medical disorder/condition in their family. Discrimination may include barriers to obtaining health, life or long-term care insurance, or obtaining employment.
Genetic studies have raised concern as to whether the studies would place research participants at risk for discrimination based on genetics. The federal Genetic Information Nondiscrimination Act (GINA) was passed to address this concern. GINA makes it illegal for medical insurance companies and most employers to discriminate based on genetic information. The protections of GINA do not apply to life, disability or long-term care insurance. Although there are substantial protections against the risk of discrimination, you should be aware of this general concern.
Extensive efforts are made to protect all research subjects from prejudice, discrimination, or uses of this information that will adversely affect them. Section N of this document details how your identifiable information will be protected. In addition, clinical and research information with respect to this study is maintained in a research file separate from hospital medical records and will not intentionally be placed in the official Cedars-Sinai medical record by research staff.
In addition, there may be discomforts or risks to you which are presently not foreseeable.
You will not likely benefit directly from taking part in this study. Neither you nor your physician will receive the results of this research because it is still preliminary and we do not yet know what the results of the tests might mean.
The study of your blood samples may, one day, result in new tests or treatments, or may help to prevent or cure IBD. Scientific knowledge often advances slowly, but it may greatly benefit future generations.
You may choose not to participate in this study. Your medical care will not be changed in any way as a result of this decision.
When this information is gathered from your past medical records and/or new medical information about you is created and used for the research study, it may or may not include information that identifies you, such as your name, Social Security Number, medical record number, address, and more. When the medical information includes any of these "identifiers," the medical record information is called "identifiable health information." If all of the identifiers have been removed from the medical information, it is called "de-identified health information." Using or giving other people "de-identified health information" does not affect your privacy. However, this particular research study requires the research team to create, use and disclose "identifiable health information."
Information about you to be recorded for the purposes of this study includes:
- Street address (city, county, precinct, zip code, and their equivalent geocodes)
- Birth date
- Admission date/ discharge date
- Date of death
- Telephone numbers
- Fax numbers
- Electronic mail addresses
- Social Security numbers
- Medical record numbers
Any other unique identifying number, characteristic, or code (except one assigned by the research study as long as it is not derived from or related to information about the individual and is not capable of being translated and used to identify the individual, and only specific researchers have access to the unique code.
You have the right to allow, or to refuse to allow, the research team to create and use and give other people (listed below) your identifiable health information. At the end of this consent form is a paragraph that asks for your signature, to authorize the research team to create and use and give other people (listed below) your identifiable health information for purposes of this research study.
The research team will share information among themselves as part of the research study process. In addition, various institutional committees and governmental agencies that oversee research may request or require access to your identifiable health information. These include one or more Institutional Review Boards of Cedars-Sinai Medical Center, in an oversight capacity, the Cedars-Sinai Office for Research Compliance, the Food and Drug Administration, the Department of Health and Human Services, and other agencies that must receive reports about certain diseases.
You should be aware that when you authorize the disclosure of your health information by signing at the end of this form, the person or organization might not be required by federal privacy law to keep it confidential. However, California law explicitly prohibits the recipient of your health information from re-disclosing that information without another signed authorization form from you, unless the recipient is required or allowed by law to make a particular disclosure.
Protections from Forced Disclosures (Subpoenas) – Certificates of Confidentiality
To further protect your private identifiable information, we have obtained a Certificate of Confidentiality (Certificate) from the federal government. Under subpoena, Cedars-Sinai Medical Center may be asked to reveal data that would include your private information. The Certificate is intended to prevent Cedars-Sinai Medical Center from being forced to share your research records under any circumstances, including a subpoena.
While the Certificate protects against forced sharing, Cedars-Sinai Medical Center institutional policy requires that all research personnel follow certain reporting requirements of the State of California. This means that investigators at Cedars-Sinai Medical Center must act on and possibly share information about the possible abuse or harm to a child, dependent adult, elder, yourself or another person, even if a Certificate is in place. If the research team receives this type of information, the research team will take measures to protect the appropriate individuals from further abuse or harm.
If you withdraw from this study you may request to have your sample destroyed. However, if parts of your sample have already been shared with other researchers it may not be possible to destroy your entire sample, as portions may be unlinked from your identifying information.
You and your insurance company will not be charged for your participation in this research.
You will not receive monetary compensation for your participation, but we will reimburse any costs, which occur as part of your participation, such as transportation, blood drawing fee, postage, etc.
In the event of injury or illness resulting from this study, you should immediately contact one of the personnel listed below.
For questions about the study or a research-related injury, contact:
- Debbie Dutridge, MA (Genetics Study Coordinator): 310-423-6451
- Stephan R. Targan, MD, Dermot McGovern, MD, Andrew Ippoliti, MD, Eric Vasiliauskas, MD, Gil Melmed, MD, and David Shih, MD: 310-423-4100
- Phillip Fleshner, MD: 310-389-0926.
After hours and on weekends, call the Medical Center's Emergency Room at 310-423-2295.
For questions about your rights as a research participant, contact the Cedars-Sinai Medical Center Institutional Review Board (CSMC-IRB) office at 310-423-3783. The IRB is a group of people who review the research to protect your rights and welfare.
Taking part in this study is voluntary. You may choose not to take part or may leave the study at any time. Your decision not to participate or to withdraw from the study means that you will not or will no longer undergo any research-related procedures. You will, however, still be able to receive treatment and services at Cedars-Sinai Medical Center that are not related to this research. If you leave the study:
- We will no longer be able to allow you to participate in the research study; and
- We will stop collecting any additional identifiable health information about you. However, we are allowed by law to continue to use the health information we already have about you, as necessary to maintain the integrity of the research study and make reports that oversight agencies require of us.
- You also have the right to revoke or withdraw your authorization for us to use your identifiable health information. If you wish to revoke or withdraw your authorization, you must do so in writing, and provide that written revocation to the investigator Dermot McGovern, MD, whose mailing address is: 8700 Beverly Blvd., Los Angeles, CA, 90048.
- In addition, if we have provided your identifiable health information to the National Institutes of Health (NIH) or the Data Coordinating Center, that information cannot be withdrawn.
During your participation in this study, we will tell you about any new information that may affect your health, welfare, or willingness to stay in this study.