Status:
UNKNOWN
The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Louise and Alan Edwards Foundation
Conditions:
Fibromyalgia
Diet, Gluten-Free
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ch...
Eligibility Criteria
Inclusion
- Women over the age of 18, diagnosed with FM.
- Chronic widespread pain index \>= 9 and pain intensity \>= 6.
- Able to read and write in either French or English.
Exclusion
- Any major illness (e.g. malignancy, active inflammatory disease, metabolic disease, etc.)
- Inflammatory bowel disease.
- Severe depression (HADS score for depression \> 10).
- Current use of LFD or GFD.
- Pregnancy
- 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.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05329571
Start Date
March 12 2021
End Date
June 30 2024
Last Update
October 18 2022
Active Locations (1)
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1
Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4