Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

NCT03948854 | Completed

• 1 other identifier: 18-011391
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Registered dietitian education

EXPERIMENTAL

Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in person by a registered dietitian

Other: Registered dietitian

On-line video program education

EXPERIMENTAL

Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet using an on-line video program

Other: On-line video program

Handout education

EXPERIMENTAL

Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet by a printed handout

Other: Printed handout

Dietitian-led group education

EXPERIMENTAL

Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in a dietitian-led group setting

Other: Dietitian-led group

Interventions

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

Registered dietitian education

On-line video program OTHER

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

On-line video program education

Printed handout OTHER

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

Handout education

Dietitian-led group OTHER

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

Dietitian-led group education

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Brian Lacy, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: May 22, 2019
• Primary Completion: February 19, 2022
• Study Completion: February 19, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)