NCT05831306

A Clinical Trial Evaluating Diets for IBS

A Randomized Clinical Trial Evaluating Two Different Diets for IBS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	Diet A	Modified Diet A
OTHER	Diet B	Modified Diet B

Timeline

• Start date: 2021-07-21
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-04-26
• Last updated: 2023-04-28

Locations

2 sites across 1 country: United States