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NCT03948854 Clinical Trial

Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

IBS - Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03948854
Other study ID # 18-011391
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 22, 2019
Est. completion date February 19, 2022

Study information
Verified date December 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date February 19, 2022
Est. primary completion date February 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• On-line video program
Education on low FODMAP diet is provided by an on-line program via a link sent through email
• Printed handout
Education on low FODMAP diet is provided through printed handout material at the initial visit.
• Dietitian-led group
Education on low FODMAP diet is provided in a dietitian-led group setting

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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