Skip to main content
OpenTrials
Completed

NCT Number: NCT03948854

Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

Researchers are trying to determine the best course of action regarding the dietary management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP diet) for irritable bowel syndrome.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

An analysis of different educational programs providing information on the low FODMAP diet will be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects (18-75 years) seen in the primary care clinic or in the Gastroenterology clinic at Mayo Clinic Florida, who are diagnosed with IBS by Rome IV criteria

Exclusion criteria

  • Subjects who have previously tried the low FODMAP diet (whether successful or not)
  • Current or recent (less than 4 weeks) opioid use
  • Current or recent (less than 10 weeks) rifaximin use
  • Inability to speak or read English
  • Pregnancy and/or breast-feeding
  • Medical or psychological issues that would prevent modifying their diet for 8 weeks.

Treatment and study plan

Registered dietitian

Other

Education on low FODMAP diet is provided in person by a registered dietitian who is an expert on the low FODMAP diet

On-line video program

Other

Education on low FODMAP diet is provided by an on-line program via a link sent through email

Printed handout

Other

Education on low FODMAP diet is provided through printed handout material at the initial visit.

Dietitian-led group

Other

Education on low FODMAP diet is provided in a dietitian-led group setting

Primary outcomes

  1. Improvement in IBS symptoms

    Time frame: Baseline, end of study approximately 8 to 10 weeks

    Change in IBS symptoms will be measured from baseline to the end of study using the validated IBS symptoms severity scale (IBS-SS). This is a visual analog scale from 0-100. The primary outcome measure is improvement in symptom scores from end of study to baseline.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients: Which Educational Method Works Best

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 14, 2019
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.