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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Patients of this group will have dietary consultation but will not change their regular diet for the period of the study.
Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, Canada
Changes in gut microbiome composition in response to dietary intervention
Genome structure, structural variants - Differential abundance analysis will be performed using 16S rRNA.
Time frame: 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.
Time frame: 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.
Time frame: Four weeks after the initiation of the new diet compared to baseline.
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.
Time frame: Four weeks after the initiation of the new diet compared to baseline.
The Fibromyalgia Impact Questionnaire (FIQ) score
A 10 items questionnaire evaluating physical functioning, work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
Time frame: Four weeks after the initiation of the new diet compared to baseline.
Hospital Anxiety and Depression Scale (HADS) score
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A 14-items questionnaire assessing the level of depression and anxiety.
Time frame: 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.
Time frame: Four weeks after the initiation of the new diet compared to baseline.
ROME IV criteria for irritable bowel syndrome
Four yes-or-no items
Time frame: Four weeks after the initiation of the new diet compared to baseline.