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Mediterranean vs Low-FODMAP Diet for Irritable Bowel Syndrome

N/A
Recruiting
Led By Prashant Singh, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if the Mediterranean and low FODMAP diets are equally effective in treating IBS symptoms like pain and bloating.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include initial discomfort such as digestive changes while adapting to new foods but are generally considered safe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients that are responders based on the abdominal pain intensity score for at least 2 of the 4 weeks
Secondary study objectives
Change in mean score of the Irritable Bowel Severity Scoring System (IBS-SSS) modified version
Proportion of patients that are weekly responders based on the Irritable Bowel Severity Scoring System (IBS-SSS) modified version for at least 2 of the 4 weeks
Proportion of patients that are weekly responders to adequate relief symptom assessment for at least 2 of the 4 weeks
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Diet low in all FODMAP groupsExperimental Treatment1 Intervention
Group II: Diet - MediterraneanExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

ModifyHealthUNKNOWN
University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,432,987 Total Patients Enrolled
13 Trials studying Irritable Bowel Syndrome
943 Patients Enrolled for Irritable Bowel Syndrome
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,444 Previous Clinical Trials
4,331,186 Total Patients Enrolled
28 Trials studying Irritable Bowel Syndrome
3,913 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Low FODMAP Diet Clinical Trial Eligibility Overview. Trial Name: NCT05807919 — N/A
Irritable Bowel Syndrome Research Study Groups: Diet - Mediterranean, Diet low in all FODMAP groups
Irritable Bowel Syndrome Clinical Trial 2023: Low FODMAP Diet Highlights & Side Effects. Trial Name: NCT05807919 — N/A
Low FODMAP Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05807919 — N/A
~0 spots leftby Dec 2024