A Randomized Clinical Trial Evaluating Two Different Diets for IBS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Abdominal Pain Intensity
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Abdominal Pain Intensity
Time Frame: 28 days
Proportion of weekly responders. A weekly responder is defined as a decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline.
Secondary Outcomes
- Irritable Bowel Syndrome - Symptom Severity Score(28 days)
- Abdominal Discomfort Intensity(28 days)
- Abdominal Bloating Intensity(28 days)
- Adequate Relief(28 days)
- Composite Score(28 days)
- Stool Consistency(28 days)