CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Diet low in all FODMAP groups +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05807919
NCT05807919N/ACompleted
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Evaluate and Compare the Clinical Efficacy of the Mediterranean Diet to the Low-FODMAP Diet in Treating Irritable Bowel Syndrome

University of Michigan·interventional·Posted Apr 11, 2023·Updated Mar 28, 2025

In Brief

A clinical study evaluating Diet low in all FODMAP groups and Diet - Mediterranean for Irritable Bowel Syndrome. Completed, enrolled 26 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesUnited States
CollaboratorsModifyHealth, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
202420252026
First PostedApr 11, 2023
Enrollment StartApr 10, 2023
Primary CompletionNov 3, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.2 years ago

Interventions

Diet low in all FODMAP groupsother

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 - Mediterraneanother

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.