Back to resultsImplementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Primary Purpose
IBS - Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Registered dietitian
On-line video program
Printed handout
Dietitian-led group
Sponsored by
About this trial
This is an interventional supportive care trial for IBS - Irritable Bowel Syndrome
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.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Registered dietitian education
On-line video program education
Handout education
Dietitian-led group education
Arm Description
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in person by a registered dietitian
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet using an on-line video program
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet by a printed handout
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in a dietitian-led group setting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03948854
Brief Title
Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients
Official Title
Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients: Which Educational Method Works Best
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
February 19, 2022 (Actual)
Study Completion Date
February 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Registered dietitian education
Arm Type
Experimental
Arm Description
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in person by a registered dietitian
Arm Title
On-line video program education
Arm Type
Experimental
Arm Description
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet using an on-line video program
Arm Title
Handout education
Arm Type
Experimental
Arm Description
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet by a printed handout
Arm Title
Dietitian-led group education
Arm Type
Experimental
Arm Description
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in a dietitian-led group setting
Intervention Type
Other
Intervention Name(s)
Registered dietitian
Intervention Description
Education on low FODMAP diet is provided in person by a registered dietitian who is an expert on the low FODMAP diet
Intervention Type
Other
Intervention Name(s)
On-line video program
Intervention Description
Education on low FODMAP diet is provided by an on-line program via a link sent through email
Intervention Type
Other
Intervention Name(s)
Printed handout
Intervention Description
Education on low FODMAP diet is provided through printed handout material at the initial visit.
Intervention Type
Other
Intervention Name(s)
Dietitian-led group
Intervention Description
Education on low FODMAP diet is provided in a dietitian-led group setting
Primary Outcome Measure Information:
Title
Improvement in IBS symptoms
Description
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.
Time Frame
Baseline, end of study approximately 8 to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Lacy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients
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