CClinicalTrials.gg
CompletedNCT03948854Updated Dec 14, 2022

Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

An interventional study of Registered dietitian and On-line video program in IBS - Irritable Bowel Syndrome, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • IBS - Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 49 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Registered dietitian education

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

    Other: Registered dietitian

  • Experimental
    On-line video program education

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

    Other: On-line video program

  • Experimental
    Handout education

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

    Other: Printed handout

  • Experimental
    Dietitian-led group education

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

    Other: Dietitian-led group

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

06

What researchers measure

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.

    Time frame: Baseline, end of study approximately 8 to 10 weeks

07

Study locations

1 site
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
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References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03948854
Lead sponsor
Mayo Clinic
Responsible party
Brian E. Lacy (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
May 14, 2019
Start date
May 22, 2019
Primary completion
Feb 19, 2022
Completion
Feb 19, 2022
Last update
Dec 14, 2022

Study contacts

Brian Lacy, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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