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Completed

NCT Number: NCT04526808

Effects of Low FODMAP Diet on Leaky Gut

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FODMAP Diet

Other

low FODMAP diet

Primary outcomes

  1. colonic permeability

    Time frame: 4 weeks

    Lactulose:Mannitol ratio pre and post treatment

Secondary outcomes

  1. colonic immune cells

    Time frame: 4 weeks

    expression of tight junction proteins pre and post treatment using RT-PCR

  2. colonic microbiome

    Time frame: 4 weeks

    relative stool microbial abundance pre and post treatment measured using 16s RNA

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2020
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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