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

Last updated: May 24, 2024
Sponsor: University of Michigan
Overall Status: Completed

Phase

N/A

Condition

Stomach Discomfort

Colic

Bowel Dysfunction

Treatment

a low FODMAP diet for 4 weeks

Clinical Study ID

NCT04542018
HUM00166423
K23DK129327
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: a low FODMAP diet for 4 weeks
Phase:
Study Start date:
August 03, 2020
Estimated Completion Date:
May 15, 2024

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.