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

Primary Purpose

Fibromyalgia, Diet, Gluten-Free

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low-FODMAP diet
Gluten-free Diet
Control group
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Alan Edwards Pain Management Unit - Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Low-FODMAP Diet

Gluten-Free Diet

Control

Arm Description

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).

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

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

Outcomes

Primary Outcome Measures

Changes in gut microbiome composition in response to dietary intervention
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.
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
Metabolomics analysis will be performed (Metabolon, USA) - targeted metabolomic for bile acids and SCFA analysis.

Secondary Outcome Measures

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.
The Fibromyalgia Impact Questionnaire (FIQ) score
A 10 items questionnaire evaluating physical functioning, work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
Hospital Anxiety and Depression Scale (HADS) score
A 14-items questionnaire assessing the level of depression and anxiety.
The Pittsburg Sleep Quality Index scores
An 11 item sleep quality evaluation questionnaire.
ROME IV criteria for irritable bowel syndrome
Four yes-or-no items

Full Information

First Posted
February 22, 2022
Last Updated
October 14, 2022
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Louise and Alan Edwards Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05329571
Brief Title
The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms
Official Title
Microbiome Correlates of Dietary Interventions in Patients With Fibromyalgia and Their Association With Symptom Modification
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Louise and Alan Edwards Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Diet, Gluten-Free

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-FODMAP Diet
Arm Type
Experimental
Arm Description
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).
Arm Title
Gluten-Free Diet
Arm Type
Experimental
Arm Description
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Arm Title
Control
Arm Type
Other
Arm Description
Patients of this group will be asked to adhere to their regular, daily diet.
Intervention Type
Behavioral
Intervention Name(s)
Low-FODMAP diet
Intervention Description
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Intervention Type
Behavioral
Intervention Name(s)
Gluten-free Diet
Intervention Description
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Patients of this group will have dietary consultation but will not change their regular diet for the period of the study.
Primary Outcome Measure Information:
Title
Changes in gut microbiome composition in response to dietary intervention
Description
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.
Title
Changes in stool microbiota-related metabolites affecting host physiology, in response to dietary intervention.
Description
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.
Title
Changes in blood microbiota-related metabolites, affecting host physiology, in response to dietary intervention
Description
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.
Secondary Outcome Measure Information:
Title
The Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC) scores.
Description
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.
Title
The Fibromyalgia Impact Questionnaire (FIQ) score
Description
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.
Title
Hospital Anxiety and Depression Scale (HADS) score
Description
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.
Title
The Pittsburg Sleep Quality Index scores
Description
An 11 item sleep quality evaluation questionnaire.
Time Frame
Four weeks after the initiation of the new diet compared to baseline.
Title
ROME IV criteria for irritable bowel syndrome
Description
Four yes-or-no items
Time Frame
Four weeks after the initiation of the new diet compared to baseline.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoram Shir, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alan Edwards Pain Management Unit - Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26918908
Citation
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.
Results Reference
background
PubMed Identifier
31219947
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.
Results Reference
background
PubMed Identifier
27906159
Citation
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.
Results Reference
background
PubMed Identifier
24260458
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.
Results Reference
background
PubMed Identifier
26214836
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.
Results Reference
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PubMed Identifier
32878326
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):2664. doi: 10.3390/nu12092664.
Results Reference
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The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms

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