Effects of Low FODMAP Diet on Leaky Gut

Not Applicable

Active, not recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: FODMAP diet

• Registration Number: NCT04526808
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-20
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-26
• Primary Completion: 2021-06-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-12
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FODMAP diet	FODMAP diet	-

Primary Outcome Measures

Name	Time	Method
colonic permeability	4 weeks	Lactulose:Mannitol ratio pre and post treatment

Secondary Outcome Measures

Name	Time	Method
colonic immune cells	4 weeks	expression of tight junction proteins pre and post treatment using RT-PCR
colonic microbiome	4 weeks	relative stool microbial abundance pre and post treatment measured using 16s RNA

Trial Locations

Locations (2)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States