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Diets for Irritable Bowel Syndrome
N/A
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
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 28 days
Awards & highlights
Study Summary
This trial assesses the effectiveness of dietary interventions in relieving IBS symptoms, with the widely recommended Low-FODMAP diet being one of them.
Who is the study for?
This trial is for adults aged 18-65 with IBS-D, diagnosed by the Rome IV criteria, who don't have serious symptoms like unexplained bleeding or weight loss. Participants must not have certain dietary restrictions or a history of eating disorders, diabetes, celiac disease, inflammatory bowel diseases, or allergies to eggs, peanuts, or milk.Check my eligibility
What is being tested?
The study compares two different diets designed to ease IBS symptoms. Diet A and Diet B are being tested for their effectiveness in providing relief from IBS compared to the standard low-FODMAP diet which can be hard and expensive to follow.See study design
What are the potential side effects?
While specific side effects aren't listed for these diets, changes in diet can sometimes cause temporary digestive discomfort such as gas or bloating as the body adjusts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abdominal Pain Intensity
Secondary outcome measures
Abdominal Bloating Intensity
Abdominal Discomfort Intensity
Adequate Relief
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Diet BExperimental Treatment1 Intervention
Modified Diet B
Group II: Diet AExperimental Treatment1 Intervention
Modified Diet A
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,276 Total Patients Enrolled
7 Trials studying Irritable Bowel Syndrome
665 Patients Enrolled for Irritable Bowel Syndrome
University of MichiganOTHER
1,794 Previous Clinical Trials
6,373,856 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
892 Patients Enrolled for Irritable Bowel Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious eating disorder that needed medical or behavioral treatment in the past 10 years.You have a history of either needing insulin or not needing insulin to manage your diabetes.You have experienced severe abdominal pain with an average score of 3.0 or higher on a scale of 0 to 10 in the past week.You have been diagnosed with celiac disease, inflammatory bowel disease, or microscopic colitis in the past.You have a known food allergy to eggs, peanuts, or milk. If you have lactose intolerance and are experiencing symptoms of irritable bowel syndrome (IBS) while on a lactose-free diet, you will not be excluded from the study.You have been following a special diet for irritable bowel syndrome (IBS) such as a low-fat diet, low FODMAP diet, or gluten-free diet in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Diet A
- Group 2: Diet B
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.
Are individuals aged 40 or above eligible to participate in this experiment?
"This study is limited to adults aged 18-65, but there are 16 trials open for minors and 93 available for seniors."
Answered by AI
Which demographics are being targeted for inclusion in this clinical experiment?
"To be accepted into this trial, candidates must have a diagnosis of irritable bowel syndrome and inhabit the age range between 18-65. The research team is aiming to recruit roughly 60 participants for this study."
Answered by AI
Are there any remaining openings for participation in this experiment?
"Affirmative. Clinicaltrials.gov records show that this experiment, which was initially posted on July 21st 2021, is currently searching for participants. The trial aims to recruit 60 individuals from 2 locations across the country."
Answered by AI
What is the participation rate of individuals in this research experiment?
"Affirmative. The information hosted on clinicaltrials.gov suggests that this medical investigation is currently in search of participants, with its initial posting occurring on July 21st 2021 and a recent update to the trial made April 27th 2023. In total, 60 patients are necessary for recruitment at two separate sites."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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