Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)

Last updated: March 7, 2025
Sponsor: University of Michigan
Overall Status: Completed

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Colic

Lactose Intolerance

Treatment

Diet low in all FODMAP groups

Diet - Mediterranean

Clinical Study ID

NCT05807919
HUM00227491
5P30DK089503-13
  • Ages 18-70
  • All Genders

Study Summary

This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS).

The study team hypothesizes that:

  • The low FODMAP and Mediterranean groups will achieve a similar improvement in abdominal pain

  • Both groups will achieve similar improvements in bloating, overall IBS symptom severity, and adequate relief

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with IBS-D (diarrhea-predominant IBS) or IBS-M (IBS with mixed subtype)diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, personal history of celiacdisease, microscopic colitis, inflammatory bowel disease)

  • Aged 18-70 years at the time of screening

  • Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 ona 0-to-10-point scale

  • At least 80 percent compliance in daily questionnaire entries during the 7-dayscreening period

Exclusion

Exclusion Criteria:

  • Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, orgluten-free diet, Mediterranean currently or within the past 6 months

  • Subjects with a known food allergy to eggs, seafood, peanuts, tree nuts or milk (subjects with lactose intolerance that are experiencing IBS symptoms while on alactose-free diet will not be excluded from the study).

  • Subjects with a history of poorly controlled insulin-dependent ornon-insulin-dependent diabetes

  • Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., celiacdisease, inflammatory bowel disease or microscopic colitis)

  • Subjects with a history of an eating disorder requiring medical or behavioraltreatment within the past 10 years.

  • Subjects with prior small bowel or colonic surgery (excluding appendectomy orcholecystectomy if over 6 months since these 2 procedures)

  • Oral antibiotic use in the past 3 months

  • Any planned significant changes in dietary or exercise regimen within 30 days priorto Screening or during the study.

  • Currently pregnant or breastfeeding.

Study Design

Total Participants: 26
Treatment Group(s): 2
Primary Treatment: Diet low in all FODMAP groups
Phase:
Study Start date:
April 10, 2023
Estimated Completion Date:
November 03, 2023

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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