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

Fibromyalgia Clinical Trial

Official title:

Microbiome Correlates of Dietary Interventions in Patients With Fibromyalgia and Their Association With Symptom Modification

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05329571
• Other study ID #: Diet-FM/2020-6134
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 12, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diet, Gluten-Free
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Alan Edwards Pain Management Unit - Montreal General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Louise and Alan Edwards Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. Review. — View Citation

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). pii: E2664. doi: 10.3390/nu12092664. — View Citation

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. — View Citation

Thaiss CA, Itav S, Rothschild D, Meijer MT, Levy M, Moresi C, Dohnalová 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	ROME IV criteria for irritable bowel syndrome	Four yes-or-no items	Four weeks after the initiation of the new diet compared to baseline.