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

University of Michigan

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: a low FODMAP diet for 4 weeks

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04542018

HUM00166423

K23DK129327 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Study patients with IBS-D

Experimental group

Description:

Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks

Treatment:

Other: a low FODMAP diet for 4 weeks