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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients that are responders based on the abdominal pain intensity score for at least 2 of the 4 weeks
Secondary outcome measures
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 moreTrial 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?
University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,373,886 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
922 Patients Enrolled for Irritable Bowel Syndrome
ModifyHealthUNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,036 Total Patients Enrolled
23 Trials studying Irritable Bowel Syndrome
3,582 Patients Enrolled for Irritable Bowel Syndrome
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is geriatric participation allowed in this experiment?
"According to the study's eligibility requirements, candidates must fall within an age range of 18 and 70 years old."
Answered by AI
For whom is this clinical trial open to participate in?
"Aspirants who desire to be part of this study must meet the age requirements (18-70) and are suffering from irritable bowel syndrome. The trial is looking for approximately 20 participants."
Answered by AI
Are there opportunities for participation in this research endeavor?
"Based on the information available on clinicaltrials.gov, it appears that this medical trial is not actively enrolling patients at present; its posting date was April 1st 2023 and has been amended as recently as March 29th 2023. Nonetheless, there are a plethora of other trials in need of volunteers - 1467 to be exact!"
Answered by AI
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