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Effects of Low FODMAP Diet on Leaky Gut

Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04526808
Enrollment
14
Registered
2020-08-26
Start date
2019-05-20
Completion date
2021-06-01
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

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.

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 abundance 3.The effect of LFD on colonic mucosal microbiome

Interventions

low FODMAP diet

Sponsors

University of Michigan
CollaboratorOTHER
Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
colonic permeability4 weeksLactulose:Mannitol ratio pre and post treatment

Secondary

MeasureTime frameDescription
colonic immune cells4 weeksexpression of tight junction proteins pre and post treatment using RT-PCR
colonic microbiome4 weeksrelative stool microbial abundance pre and post treatment measured using 16s RNA

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026