The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms
NCT ID: NCT05329571
Last Updated: 2022-10-18
Study Results
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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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-03-12
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
Low-FODMAP diet
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Gluten-Free Diet
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Gluten-free Diet
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Control
Patients of this group will be asked to adhere to their regular, daily diet.
Control group
Patients of this group will have dietary consultation but will not change their regular diet for the period of the study.
Interventions
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Low-FODMAP diet
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Gluten-free Diet
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Control group
Patients of this group will have dietary consultation but will not change their regular diet for the period of the study.
Eligibility Criteria
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Inclusion Criteria
2. Chronic widespread pain index \>= 9 and pain intensity \>= 6.
3. Able to read and write in either French or English.
Exclusion Criteria
2. Inflammatory bowel disease.
3. Severe depression (HADS score for depression \> 10).
4. Current use of LFD or GFD.
5. Pregnancy
6. Vegan diet
18 Years
FEMALE
No
Sponsors
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Louise and Alan Edwards Foundation
UNKNOWN
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Dr. Yoram Shir
Director of the Alan Edwards Pain Management Unit
Principal Investigators
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Yoram Shir, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, Canada
Countries
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References
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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.
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.
Thaiss CA, Itav S, Rothschild D, Meijer MT, Levy M, Moresi C, Dohnalova L, Braverman S, Rozin S, Malitsky S, Dori-Bachash M, Kuperman Y, Biton I, Gertler A, Harmelin A, Shapiro H, Halpern Z, Aharoni A, Segal E, Elinav E. Persistent microbiome alterations modulate the rate of post-dieting weight regain. Nature. 2016 Dec 22;540(7634):544-551. doi: 10.1038/nature20796. Epub 2016 Nov 24.
Tong M, Li X, Wegener Parfrey L, Roth B, Ippoliti A, Wei B, Borneman J, McGovern DP, Frank DN, Li E, Horvath S, Knight R, Braun J. A modular organization of the human intestinal mucosal microbiota and its association with inflammatory bowel disease. PLoS One. 2013 Nov 19;8(11):e80702. doi: 10.1371/journal.pone.0080702. eCollection 2013.
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.
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.
Other Identifiers
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Diet-FM/2020-6134
Identifier Type: -
Identifier Source: org_study_id
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