Mediterranean vs Low-FODMAP Diet for Irritable Bowel Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byPrashant Singh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Adults aged 18-70 with IBS-D or IBS-M, experiencing abdominal pain and able to fill out a daily questionnaire. Excluded are those with certain GI diseases, recent surgeries, significant diet changes, eating disorders in the last decade, current pregnancy or breastfeeding, specific food allergies, or recent antibiotic use.

Inclusion Criteria

I have IBS with mostly diarrhea or mixed symptoms, and no severe warning signs like unexplained weight loss or bleeding.

I am between 18 and 70 years old.

At least 80 percent compliance in daily questionnaire entries during the 7-day screening period

See 1 more

Exclusion Criteria

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)

Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study

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

See 6 more

Treatment Details

Interventions

Low FODMAP Diet (Behavioural Intervention)
Mediterranean Diet (Behavioural Intervention)

Trial OverviewThe trial is testing if a Mediterranean Diet is as effective as a low FODMAP diet for treating IBS symptoms like abdominal pain and bloating. Participants will follow one of these diets to see if there's an improvement in their condition.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Diet low in all FODMAP groupsExperimental Treatment1 Intervention

Group II: Diet - MediterraneanExperimental Treatment1 Intervention