Effects of Low FODMAP Diet on Leaky Gut

Beth Israel Deaconess Medical Center (Other)
Overall Status
Unknown status
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: FODMAP diet

Study Design

Study Type:
Anticipated Enrollment :
40 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome
Actual Study Start Date :
May 20, 2019
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: FODMAP diet

Other: FODMAP diet
low FODMAP diet

Outcome Measures

Primary Outcome Measures

  1. colonic permeability [4 weeks]

    Lactulose:Mannitol ratio pre and post treatment

Secondary Outcome Measures

  1. colonic immune cells [4 weeks]

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

  2. colonic microbiome [4 weeks]

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

Eligibility Criteria


Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
2 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • Beth Israel Deaconess Medical Center


  • Principal Investigator: Anthony Lembo, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Anthony Lembo, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 2019P000149
First Posted:
Aug 26, 2020
Last Update Posted:
Aug 26, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2020