Diet, Gluten-Free, Fibromyalgia
Conditions
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).
Interventions
BEHAVIORALLow-FODMAP diet
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
BEHAVIORALGluten-free Diet
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
BEHAVIORALControl group
Patients of this group will have dietary consultation but will not change their regular diet for the period of the study.
Sponsors
Louise and Alan Edwards Foundation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gut microbiome composition in response to dietary intervention | Four weeks after the initiation of the new diet compared to baseline. | Genome structure, structural variants - Differential abundance analysis will be performed using 16S rRNA. |
| Changes in stool microbiota-related metabolites affecting host physiology, in response to dietary intervention. | Four weeks after the initiation of the new diet compared to baseline. | Metabolomics analysis will be performed (Metabolon, USA) - targeted metabolomic for bile acids and SCFA analysis. |
| Changes in blood microbiota-related metabolites, affecting host physiology, in response to dietary intervention | Four weeks after the initiation of the new diet compared to baseline. | Metabolomics analysis will be performed (Metabolon, USA) - targeted metabolomic for bile acids and SCFA analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Pittsburg Sleep Quality Index scores | Four weeks after the initiation of the new diet compared to baseline. | An 11 item sleep quality evaluation questionnaire. |
| The Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC) scores. | Four weeks after the initiation of the new diet compared to baseline. | 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. |
| ROME IV criteria for irritable bowel syndrome | Four weeks after the initiation of the new diet compared to baseline. | Four yes-or-no items |
| The Fibromyalgia Impact Questionnaire (FIQ) score | Four weeks after the initiation of the new diet compared to baseline. | A 10 items questionnaire evaluating physical functioning, work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression. |
| Hospital Anxiety and Depression Scale (HADS) score | Four weeks after the initiation of the new diet compared to baseline. | A 14-items questionnaire assessing the level of depression and anxiety. |
Countries
Canada
Outcome results
None listed