The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)
United States38 participantsStarted 2017-02-01
Plain-language summary
The goal of this study is to prospectively test the hypothesis that specific dietary modification can improve patient symptoms by promoting beneficial changes in the composition of the microbiome that, in turn, alter the immune response in such a way as to and ameliorate inflammatory conditions such as Inflammatory Bowel Disease (IBD). The potential long term benefit of this research is a validated set of efficacious dietary guidelines for persons with IBD. The potential immediate benefit to patients is symptomatic relief and healing.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- 15 years of age or older
* Willingness and capacity to significantly change diet
* Willing and able to comply with scheduled visits, blood, and stool collection, and other study procedures and to complete the study
* Clinical provider (GI clinician) permission for IBD patients to participate in the intervention is required for participation in the study.
* Evidence of personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* For children age 15 and above, the assent of the child and consent of a parent or legal guardian will be required.
* One of the following:
* diagnosis of IBD, specifically Crohn's Disease and Ulcerative Colitis
* healthy control
Exclusion Criteria:
* the presence of infection (such as C.diff) precipitating the colitis
* antibiotics taken within 3 months of study entry
* medically unstable to give consent
* on heparin or Coumadin
* Prisoners
* Subjects who do not speak or understand English, to ensure that there is consistency in teaching and educational materials.
* Subjects who self-report current pregnancy
* Patients who do not receive clinical care at UMass Memorial Health Care
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.