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Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

NCT ID: NCT03948854

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2022-02-19

Brief Summary

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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

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

Conditions

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IBS - Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Registered dietitian education

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

Group Type EXPERIMENTAL

Registered dietitian

Intervention Type OTHER

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

On-line video program education

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

Group Type EXPERIMENTAL

On-line video program

Intervention Type OTHER

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

Handout education

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

Group Type EXPERIMENTAL

Printed handout

Intervention Type OTHER

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

Dietitian-led group education

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

Group Type EXPERIMENTAL

Dietitian-led group

Intervention Type OTHER

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

Interventions

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Registered dietitian

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

On-line video program

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

Intervention Type OTHER

Printed handout

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

Intervention Type OTHER

Dietitian-led group

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Brian E. Lacy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Lacy, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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18-011391

Identifier Type: -

Identifier Source: org_study_id