Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

Study Overview
=================
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.

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

Conditions
-----------------
IBS - Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Other: Registered dietitian
* Other: On-line video program
* Other: Printed handout
* Other: Dietitian-led group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |