Effects of Low FODMAP Diet on Leaky Gut
1 other identifier
interventional
14
1 country
2
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 dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2019
CompletedFirst Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedMay 23, 2025
May 1, 2025
2 years
August 5, 2020
May 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
colonic permeability
Lactulose:Mannitol ratio pre and post treatment
4 weeks
Secondary Outcomes (2)
colonic immune cells
4 weeks
colonic microbiome
4 weeks
Study Arms (1)
FODMAP diet
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beth Israel Deaconess Medical Centerlead
- University of Michigancollaborator
Study Sites (2)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judy Nee, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 26, 2020
Study Start
May 20, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share