Effects of Low FODMAP Diet on Leaky Gut

Last updated: May 20, 2025
Sponsor: Beth Israel Deaconess Medical Center
Overall Status: Completed

Phase

N/A

Condition

Lactose Intolerance

Gastrointestinal Diseases And Disorders

Colic

Treatment

FODMAP diet

Clinical Study ID

NCT04526808
2019P000149
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged 18-65 years at the time of screening

  • normal serum studies including serum tissue-transglutaminase antibodies, thyroidstimulating hormone levels, C-reactive protein, complete blood count since the onsetof symptoms

  • normal stool studies including C diff testing, culture, ova and parasites since theonset of symptoms

  • IBS-SSS score of ≥175 at the end of 7-day screening period

Exclusion

Exclusion criteria:

  • individuals already on a LFD or other dietary restriction such as gluten free dietwithin 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-steroidalanti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids orbile-acid binder.

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: FODMAP diet
Phase:
Study Start date:
May 20, 2019
Estimated Completion Date:
June 01, 2021

Study 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

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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