A Clinical Trial Evaluating Diets for IBS

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Diet B; Other: Diet A

• Registration Number: NCT05831306
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-21
• Status Verified: 2023-04
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-04-26
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet B	Diet B	Modified Diet B
Diet A	Diet A	Modified Diet A

Primary Outcome Measures

Name	Time	Method
Abdominal Pain Intensity	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 Outcome Measures

Name	Time	Method
Abdominal Discomfort Intensity	28 days	Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal discomfort in the past 24 hours score of at least 30% compared with baseline.
Irritable Bowel Syndrome - Symptom Severity Score	28 days	Change in IBS-SSS as compared with baseline.
Abdominal Bloating Intensity	28 days	Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal bloating in the past 24 hours score of at least 30% compared with baseline.
Adequate Relief	28 days	Proportion of subjects who experience adequate relief compared with baseline.
Composite Score	28 days	Proportion of weekly composite responders. A weekly composite responder is defined as a subject who experiences a decrease in the weekly average of worst abdominal pain in the 24 hours score of at least 30% compared with baseline AND who experiences a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline
Stool Consistency	28 days	Weekly responder. A weekly responder is defined as a decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Bristol Stool Form Scale Type 6 or Type 7 compared with baseline.

Trial Locations

Locations (2)

University of Michigan - Ann Arbor; 🇺🇸 Ann Arbor, Michigan, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States