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

NCT ID: NCT05807919

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2023-11-03

Brief 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

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diet low in all FODMAP groups

Group Type: EXPERIMENTAL

Diet low in all FODMAP groups

Intervention Type: OTHER

Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.

Diet - Mediterranean

Group Type: EXPERIMENTAL

Diet - Mediterranean

Intervention Type: OTHER

Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.

Interventions

Diet low in all FODMAP groups

Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.

Intervention Type: OTHER

Diet - Mediterranean

Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ModifyHealth

UNKNOWN

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Prashant Singh

Assistant Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prashant Singh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Singh P, Dean G, Iram S, Peng W, Chey SW, Rifkin S, Lothen-Kline C, Muir J, Lee AA, Eswaran S, Chey WD. Efficacy of Mediterranean Diet vs. Low-FODMAP Diet in Patients With Nonconstipated Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial. Neurogastroenterol Motil. 2025 Oct;37(10):e70060. doi: 10.1111/nmo.70060. Epub 2025 Apr 24.

Reference Type: DERIVED

PMID: 40273380 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P30DK089503-13

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00227491

Identifier Type: -

Identifier Source: org_study_id