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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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 moreAwards & 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
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Who is running the clinical trial?
ModifyHealthUNKNOWN
University of MichiganLead Sponsor
1,854 Previous Clinical Trials
6,433,531 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
2,448 Previous Clinical Trials
4,332,374 Total Patients Enrolled
28 Trials studying Irritable Bowel Syndrome
3,913 Patients Enrolled for Irritable Bowel Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have IBS with mostly diarrhea or mixed symptoms, and no severe warning signs like unexplained weight loss or bleeding.I have had surgery on my small bowel or colon, not including recent appendectomy or cholecystectomy.I am between 18 and 70 years old.My worst daily abdominal pain is often 3 or more on a scale of 0 to 10.I have a diagnosed GI condition like celiac or inflammatory bowel disease.I have taken oral antibiotics in the last 3 months.I have a history of diabetes that is hard to control.I have not had an eating disorder that needed treatment in the last 10 years.
Research Study Groups:
This trial has the following groups:- Group 1: Diet - Mediterranean
- Group 2: Diet low in all FODMAP groups
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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