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

NCT05329571 | Unknown

• 1 other identifier: Diet-FM/2020-6134
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia; Diet, Gluten-Free

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (5)

• The Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC) scores.

  Four weeks after the initiation of the new diet compared to baseline.

• The Fibromyalgia Impact Questionnaire (FIQ) score

  Four weeks after the initiation of the new diet compared to baseline.

• Hospital Anxiety and Depression Scale (HADS) score

  Four weeks after the initiation of the new diet compared to baseline.

• The Pittsburg Sleep Quality Index scores

  Four weeks after the initiation of the new diet compared to baseline.

• ROME IV criteria for irritable bowel syndrome

  Four weeks after the initiation of the new diet compared to baseline.

Study Arms (3)

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).

Behavioral: Low-FODMAP diet

Gluten-Free Diet

EXPERIMENTAL

Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.

Behavioral: Gluten-free Diet

Control

OTHER

Patients of this group will be asked to adhere to their regular, daily diet.

Behavioral: Control group

Interventions

Low-FODMAP diet BEHAVIORAL

Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.

Low-FODMAP Diet

Gluten-free Diet BEHAVIORAL

Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.

Gluten-Free Diet

Control group BEHAVIORAL

Patients of this group will have dietary consultation but will not change their regular diet for the period of the study.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over the age of 18, diagnosed with FM.
• Chronic widespread pain index \>= 9 and pain intensity \>= 6.
• Able to read and write in either French or English.

You may not qualify if:

• Any major illness (e.g. malignancy, active inflammatory disease, metabolic disease, etc.)
• Inflammatory bowel disease.
• Severe depression (HADS score for depression \> 10).
• Current use of LFD or GFD.
• Pregnancy
• Vegan diet

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Louise and Alan Edwards Foundation: collaborator

Study Sites (1)

Alan Edwards Pain Management Unit - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related 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.

  PMID: 26918908 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.

  PMID: 31219947 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.

  PMID: 27906159 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.

  PMID: 24260458 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.

  PMID: 26214836 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.

  PMID: 32878326 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

FODMAP Diet; Diet, Gluten-Free; Control Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yoram Shir, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Alan Edwards Pain Management Unit

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: April 15, 2022
• Study Start: March 12, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 30, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)