Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

Not Applicable

Completed

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Other: Registered dietitian; Other: On-line video program; Other: Dietitian-led group; Other: Printed handout

• Registration Number: NCT03948854
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Study Start: 2019-05-22
• Primary Completion: 2022-02-19
• Study Completion: 2022-02-19
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Registered dietitian education	Registered dietitian	Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in person by a registered dietitian
On-line video program education	On-line video program	Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet using an on-line video program
Dietitian-led group education	Dietitian-led group	Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in a dietitian-led group setting
Handout education	Printed handout	Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet by a printed handout

Primary Outcome Measures

Name	Time	Method
Improvement in IBS symptoms	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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States