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Effects of Low FODMAP Diet on Leaky Gut

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04526808
Recruitment Status : Unknown
Verified August 2020 by Anthony Lembo, Beth Israel Deaconess Medical Center.
Recruitment status was:  Recruiting
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center

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
Irritable Bowel Syndrome Other: FODMAP diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: FODMAP diet Other: FODMAP diet
low FODMAP diet

Primary Outcome Measures :
  1. colonic permeability [ Time Frame: 4 weeks ]
    Lactulose:Mannitol ratio pre and post treatment

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526808

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Contact: Vivian Cheng 617.667.0682 vcheng2@bidmc.harvard.edu

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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Vivian Cheng    617-667-0682    vcheng2@bidmc.harvard.edu   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Prashant Singh, MD       singhpr@med.umich.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center
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Responsible Party: Anthony Lembo, Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04526808    
Other Study ID Numbers: 2019P000149
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases