Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

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

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.

Study Overview

• Status: Completed
• Conditions: IBS - Irritable Bowel Syndrome
• Intervention / Treatment: Other: Registered dietitian; Other: On-line video program; Other: Printed handout; Other: Dietitian-led group

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Registered dietitian education; Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in person by a registered dietitian	Other: Registered dietitian; Education on low FODMAP diet is provided in person by a registered dietitian who is an expert on the low FODMAP diet
Experimental: On-line video program education; Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet using an on-line video program	Other: On-line video program; Education on low FODMAP diet is provided by an on-line program via a link sent through email
Experimental: Handout education; Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet by a printed handout	Other: Printed handout; Education on low FODMAP diet is provided through printed handout material at the initial visit.
Experimental: Dietitian-led group education; Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in a dietitian-led group setting	Other: Dietitian-led group; Education on low FODMAP diet is provided in a dietitian-led group setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in IBS symptoms	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.	Baseline, end of study approximately 8 to 10 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brian Lacy, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Actual): February 19, 2022
• Study Completion (Actual): February 19, 2022

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 18-011391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No