Status:
COMPLETED
Effects of Low FODMAP Diet on Leaky Gut
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
University of Michigan
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dys...
Detailed Description
we aim to evaluate the following in patients with IBS-D. The effect of LFD on colonic permeability. 2.The effect of LFD on abundance of colonic mucosal immune cells specifically T-cell and mast cell a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- aged 18-65 years at the time of screening
- normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms
- normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms
- IBS-SSS score of ≥175 at the end of 7-day screening period
- Exclusion criteria:
- individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
- individuals with any known food allergy or insulin-dependent diabetes
- known history of celiac disease, inflammatory bowel disease or microscopic colitis
- prior small bowel or colonic surgery or cholecystectomy
- pregnant patients
- antibiotics in the past 3 months
- those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.
Exclusion
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04526808
Start Date
May 20 2019
End Date
June 1 2021
Last Update
May 23 2025
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
University of Michigan
Ann Arbor, Michigan, United States, 48109