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

University of Michigan

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Diet - Mediterranean; Other: Diet low in all FODMAP groups

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05807919

5P30DK089503-13 (U.S. NIH Grant/Contract)

HUM00227491

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 celiac disease, 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 on a 0-to-10-point scale
• At least 80 percent compliance in daily questionnaire entries during the 7-day screening period

Exclusion criteria

• Subjects adhering to any dietary IBS treatment such as the low-fodmap diet, or gluten-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 a lactose-free diet will not be excluded from the study).
• Subjects with a history of poorly controlled insulin-dependent or non-insulin-dependent diabetes
• Subjects with a known history of organic Gastrointestinal (GI) disease (i.e., celiac disease, inflammatory bowel disease or microscopic colitis)
• Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
• Subjects with prior small bowel or colonic surgery (excluding appendectomy or cholecystectomy 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 prior to Screening or during the study.
• Currently pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Diet low in all FODMAP groups

Experimental group

Treatment:

Other: Diet low in all FODMAP groups

Diet - Mediterranean

Experimental group

Treatment:

Other: Diet - Mediterranean