Effects of Low FODMAP Diet on Leaky Gut

NCT ID: NCT04526808

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2021-06-01

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

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

FODMAP diet

Group Type: EXPERIMENTAL

FODMAP diet

Intervention Type: OTHER

low FODMAP diet

Interventions

FODMAP diet

low FODMAP diet

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Judy Nee

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judy Nee, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

2019P000149

Identifier Type: -

Identifier Source: org_study_id