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| Name | Class |
|---|---|
| Louise and Alan Edwards Foundation | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-FODMAP Diet | Experimental | 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). |
|
| Gluten-Free Diet | Experimental | Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten. |
|
| Control | Other | Patients of this group will be asked to adhere to their regular, daily diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-FODMAP diet | Behavioral | Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gut microbiome composition in response to dietary intervention | Genome structure, structural variants - Differential abundance analysis will be performed using 16S rRNA. | Four weeks after the initiation of the new diet compared to baseline. |
| Changes in stool microbiota-related metabolites affecting host physiology, in response to dietary intervention. | Metabolomics analysis will be performed (Metabolon, USA) - targeted metabolomic for bile acids and SCFA analysis. | Four weeks after the initiation of the new diet compared to baseline. |
| Changes in blood microbiota-related metabolites, affecting host physiology, in response to dietary intervention | Metabolomics analysis will be performed (Metabolon, USA) - targeted metabolomic for bile acids and SCFA analysis. | Four weeks after the initiation of the new diet compared to baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| The Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC) scores. | assessing symptom severity, pain distribution, fatigue, sleep quality and cognitive and somatic complaints in fibromyalgia patients. A questionnaire assessing symptom severity, pain distribution, fatigue, sleep quality and cognitive and somatic complaints in fibromyalgia patients. | Four weeks after the initiation of the new diet compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Yoram Shir, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alan Edwards Pain Management Unit - Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26918908 | Background | 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. | |
| 31219947 | Background | 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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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000092622 | FODMAP Diet |
| D055050 | Diet, Gluten-Free |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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| Gluten-free Diet | Behavioral | Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten. |
|
| Control group | Behavioral | Patients of this group will have dietary consultation but will not change their regular diet for the period of the study. |
|
| The Fibromyalgia Impact Questionnaire (FIQ) score | A 10 items questionnaire evaluating physical functioning, work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression. | Four weeks after the initiation of the new diet compared to baseline. |
| Hospital Anxiety and Depression Scale (HADS) score | A 14-items questionnaire assessing the level of depression and anxiety. | Four weeks after the initiation of the new diet compared to baseline. |
| The Pittsburg Sleep Quality Index scores | An 11 item sleep quality evaluation questionnaire. | Four weeks after the initiation of the new diet compared to baseline. |
| ROME IV criteria for irritable bowel syndrome | Four yes-or-no items | Four weeks after the initiation of the new diet compared to baseline. |
| 27906159 | Background | 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. |
| 24260458 | Background | 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. |
| 26214836 | Background | 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. |
| 32878326 | Background | 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. |
| D009422 |
| Nervous System Diseases |
| D010829 | Physiological Phenomena |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |