Status:
COMPLETED
The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
15+ years
Phase:
NA
Brief 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...
Detailed Description
The gut microbiome is the community of microbes that inhabit the gastrointestinal tract. Sequencing and analysis of the DNA and/or RNA of the gut microbiome (metagenomics) allow the identification of ...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04757181
Start Date
February 1 2017
End Date
June 1 2019
Last Update
February 17 2021
Active Locations (1)
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1
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655