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The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms

NCT05329571 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-10-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of two diets - gluten-free and low-FODMAP diet- in relieving symptoms of fibromyalgia, and study whether these changes could be associated with changes in the gut microbiome (gut bacteria).

Conditions

  • Fibromyalgia
  • Diet, Gluten-Free

Interventions

BEHAVIORAL

Low-FODMAP diet

Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.

BEHAVIORAL

Gluten-free Diet

Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.

BEHAVIORAL

Control group

Patients of this group will have dietary consultation but will not change their regular diet for the period of the study.

Sponsors & Collaborators

  • Louise and Alan Edwards Foundation

    collaborator UNKNOWN

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Yoram Shir, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2022-06-15
Completion
2024-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05329571 on ClinicalTrials.gov