Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: a low FODMAP diet for 4 weeks

• Registration Number: NCT04542018
• Lead Sponsor: University of Michigan

Brief Summary

This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS). This research will show if diet might play a role in triggering changes that may cause IBS. This study is being done to learn if a low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diet causes changes in the colon lining which mediates improvement in IBS symptoms.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Status Verified: 2024-05
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein or fecal calprotectin, complete blood count since the onset of symptoms.
• Normal stool studies including, ova and parasites since the onset of symptoms
• IBS-SSS score of ≥175 at the end of the 7-day screening period

In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study patients with IBS-D	a low FODMAP diet for 4 weeks	Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks

Primary Outcome Measures

Name	Time	Method
Lactulose Mannitol excretion	4 weeks	Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet

Secondary Outcome Measures

Name	Time	Method
Changes in epithelial permeability	4 weeks	Changes in tight junction gene expression, immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet
Changes in stool microbiome	4 weeks	Changes in relative abundance of bacteria before and after low FODMAP diet

Trial Locations

Locations (2)

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

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