The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms

Not Applicable

Active, not recruiting

• Conditions: Fibromyalgia; Diet, Gluten-Free

• Registration Number: NCT05329571
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-12
• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-15
• Primary Completion: 2022-06-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
ROME IV criteria for irritable bowel syndrome	Four weeks after the initiation of the new diet compared to baseline.	Four yes-or-no items

Trial Locations

Locations (1)

Alan Edwards Pain Management Unit - Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada