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Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

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ClinicalTrials.gov Identifier: NCT03948854
Recruitment Status : Enrolling by invitation
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Brian E. Lacy, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
IBS - Irritable Bowel Syndrome Other: Registered dietitian Other: On-line video program Other: Printed handout Other: Dietitian-led group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients: Which Educational Method Works Best
Estimated Study Start Date : May 22, 2019
Estimated Primary Completion Date : May 22, 2020
Estimated Study Completion Date : May 22, 2020

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

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

Experimental: Handout education
Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet by a printed handout
Other: Printed handout
Education on low FODMAP diet is provided through printed handout material at the initial visit.

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




Primary Outcome Measures :
  1. Change in IBS symptoms [ Time Frame: Baseline, weekly for approximately 8 to 10 weeks ]
    Measured using a weekly assessment questionnaire of significantly worse to significantly better



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948854


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Brian Lacy, MD Mayo Clinic

Additional Information:
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Responsible Party: Brian E. Lacy, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03948854     History of Changes
Other Study ID Numbers: 18-011391
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases