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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03948854

Enrollment

Registered

2019-05-14

Start date

2019-05-22

Completion date

2022-02-19

Last updated

2022-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS - Irritable Bowel Syndrome

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.

Interventions

OTHERRegistered dietitian

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

OTHEROn-line video program

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

OTHERPrinted handout

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

OTHERDietitian-led group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026