NCT05831306

A Clinical Trial Evaluating Diets for IBS

Status unknown NA Last updated 28 April 2023

What this trial tests

NA trial testing Diet A in Irritable Bowel Syndrome in 60 participants. Status unknown.

Timeline

21 July 2021

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	21 July 2021
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	2 locations across United States

Drugs / interventions tested

• Diet A
• Diet B

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Beth Israel Deaconess Medical Center

Who can join

Adults 18 to 65, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Is a Simplified, Less Restrictive Low FODMAP Diet Possible? Results From a Double-Blind, Pilot Randomized Controlled Trial.
   Singh P, Chey SW, Nee J, Eswaran S, et al · · 2025 · cited 12× · PMID 38729393 · DOI 10.1016/j.cgh.2024.04.021