Skip to main content
Clinical Trials/NCT05831306
NCT05831306
Recruiting
Not Applicable

A Randomized Clinical Trial Evaluating Two Different Diets for IBS

Beth Israel Deaconess Medical Center2 sites in 1 country60 target enrollmentJuly 21, 2021

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2021
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (2)

Loading locations...

Similar Trials