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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Women over the age of 18, diagnosed with FM. 2. Chronic widespread pain index >= 9 and pain intensity >= 6. 3. Able to read and write in either French or English.

Exclusion Criteria:

1. Any major illness (e.g. malignancy, active inflammatory disease, metabolic disease, etc.) 2. Inflammatory bowel disease. 3. Severe depression (HADS score for depression > 10). 4. Current use of LFD or GFD. 5. Pregnancy. 6. Vegan diet. The inclusion/exclusion criteria were set to reduce the risk of confounding factors that could affect gut microbiota composition. To date, information on microbiome alterations in individuals with fibromyalgia is only available for female patients, and thus recruitment will be limited to women.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05329571
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yoram Shir, MD
Principal Investigator Affiliation McGill University Health Centre/Research Institute of the McGill University Health Centre
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia, Diet, Gluten-Free
Arms & Interventions

Arms

Experimental: Low-FODMAP Diet

Participants will be instructed to maintain their usual diet, while eliminating FODMAPs (A subgroup of carbohydrates are considered fermentable, given the lack of suitable hydrolase enzymes in the colon, required for their digestion and absorption, thus making them available for fermentation).

Experimental: Gluten-Free Diet

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

Other: Control

Patients of this group will be asked to adhere to their regular, daily diet.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Montreal, Quebec, Canada

Status

Recruiting

Address

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, H3G 1A4

Site Contact

Yoram Shir, MD

yoram.shir@muhc.mcgill.ca

514-934-8558

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