Clinical trial NCT05329571: The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms
Official title: Microbiome Correlates of Dietary Interventions in Patients With Fibromyalgia and Their Association With Symptom Modification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Diet, Gluten-Free
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Louise and Alan Edwards Foundation
First posted: 2022-04-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 changes in the gut microbiome (gut bacteria).


Eligibility 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.

Primary outcomes:
measure: Changes in gut microbiome composition in response to dietary intervention
timeFrame: Four weeks after the initiation of the new diet compared to baseline.
measure: Changes in stool microbiota-related metabolites affecting host physiology, in response to dietary intervention.
timeFrame: Four weeks after the initiation of the new diet compared to baseline.
measure: Changes in blood microbiota-related metabolites, affecting host physiology, in response to dietary intervention
timeFrame: Four weeks after the initiation of the new diet compared to baseline.
Secondary outcomes:
measure: The Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC) scores.
timeFrame: Four weeks after the initiation of the new diet compared to baseline.
measure: The Fibromyalgia Impact Questionnaire (FIQ) score
timeFrame: Four weeks after the initiation of the new diet compared to baseline.
measure: Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Four weeks after the initiation of the new diet compared to baseline.
measure: The Pittsburg Sleep Quality Index scores
timeFrame: Four weeks after the initiation of the new diet compared to baseline.
measure: ROME IV criteria for irritable bowel syndrome
timeFrame: Four weeks after the initiation of the new diet compared to baseline.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Alan Edwards Pain Management Unit - Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Yoram Shir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauer KC, Huus KE, Finlay BB. Microbes and the mind: emerging hallmarks of the gut microbiota-brain axis. Cell Microbiol. 2016 May;18(5):632-44. doi: 10.1111/cmi.12585. Epub 2016 Mar 31.
citation: Minerbi A, Gonzalez E, Brereton NJB, Anjarkouchian A, Dewar K, Fitzcharles MA, Chevalier S, Shir Y. Altered microbiome composition in individuals with fibromyalgia. Pain. 2019 Nov;160(11):2589-2602. doi: 10.1097/j.pain.0000000000001640.
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citation: Zhang X, Zhang D, Jia H, Feng Q, Wang D, Liang D, Wu X, Li J, Tang L, Li Y, Lan Z, Chen B, Li Y, Zhong H, Xie H, Jie Z, Chen W, Tang S, Xu X, Wang X, Cai X, Liu S, Xia Y, Li J, Qiao X, Al-Aama JY, Chen H, Wang L, Wu QJ, Zhang F, Zheng W, Li Y, Zhang M, Luo G, Xue W, Xiao L, Li J, Chen W, Xu X, Yin Y, Yang H, Wang J, Kristiansen K, Liu L, Li T, Huang Q, Li Y, Wang J. The oral and gut microbiomes are perturbed in rheumatoid arthritis and partly normalized after treatment. Nat Med. 2015 Aug;21(8):895-905. doi: 10.1038/nm.3914. Epub 2015 Jul 27.
citation: Lowry E, Marley J, McVeigh JG, McSorley E, Allsopp P, Kerr D. Dietary Interventions in the Management of Fibromyalgia: A Systematic Review and Best-Evidence Synthesis. Nutrients. 2020 Aug 31;12(9):2664. doi: 10.3390/nu12092664.