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Dietary Changes
Dietary Changes for Fibromyalgia
N/A
Waitlist Available
Led By Yoram Shir, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic widespread pain index >= 9 and pain intensity >= 6
Women over the age of 18, diagnosed with FM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks after the initiation of the new diet compared to baseline.
Awards & highlights
Study Summary
This trial will test whether a gluten-free or low-FODMAP diet can help relieve symptoms of fibromyalgia and if these changes are linked to changes in gut bacteria.
Who is the study for?
This trial is for women over 18 with fibromyalgia, experiencing widespread pain. Participants must be able to read and write in French or English. It's not suitable for those with major illnesses, severe depression, pregnancy, inflammatory bowel disease, or those already on low-FODMAP or gluten-free diets.Check my eligibility
What is being tested?
The study tests the effectiveness of a gluten-free diet versus a low-FODMAP diet compared to no dietary change (control group) in reducing fibromyalgia symptoms and altering gut bacteria.See study design
What are the potential side effects?
Dietary changes may lead to temporary digestive discomfort such as bloating or constipation. Long-term effects are unknown but could include nutritional deficiencies if not properly managed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience widespread pain almost all the time.
Select...
I am a woman over 18 diagnosed with fibromyalgia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four weeks after the initiation of the new diet compared to baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks after the initiation of the new diet compared to baseline.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in blood microbiota-related metabolites, affecting host physiology, in response to dietary intervention
Changes in gut microbiome composition in response to dietary intervention
Changes in stool microbiota-related metabolites affecting host physiology, in response to dietary intervention.
Secondary outcome measures
Hospital Anxiety and Depression Scale (HADS) score
ROME IV criteria for irritable bowel syndrome
The Fibromyalgia Impact Questionnaire (FIQ) score
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Low-FODMAP DietExperimental Treatment1 Intervention
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).
Group II: Gluten-Free DietExperimental Treatment1 Intervention
Participants will be instructed to maintain their usual diet, while eliminating all dietary gluten.
Group III: ControlExperimental Treatment1 Intervention
Patients of this group will be asked to adhere to their regular, daily diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control group
2020
N/A
~1870
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
448 Previous Clinical Trials
159,724 Total Patients Enrolled
1 Trials studying Fibromyalgia
32 Patients Enrolled for Fibromyalgia
Louise and Alan Edwards FoundationUNKNOWN
2 Previous Clinical Trials
370 Total Patients Enrolled
Yoram Shir, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
5 Previous Clinical Trials
329 Total Patients Enrolled
1 Trials studying Fibromyalgia
19 Patients Enrolled for Fibromyalgia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can read and write in either French or English.I do not have any major illnesses like cancer or metabolic diseases.I am a woman over 18 diagnosed with fibromyalgia.I experience severe and widespread pain regularly.I have inflammatory bowel disease.I have severe depression.I experience widespread pain almost all the time.I am a woman over 18 diagnosed with fibromyalgia.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Low-FODMAP Diet
- Group 2: Gluten-Free Diet
- Group 3: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Fibromyalgia Patient Testimony for trial: Trial Name: NCT05329571 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary focus of this research endeavor?
"This trial's primary outcome is the alteration of gut microbiome composition following dietary intervention, measured over a period of four weeks compared to baseline. Secondary outcomes evaluated by this study include responses to ROME IV criteria for irritable bowel syndrome (categorized as 4 binary items), Pittsburg Sleep Quality Index scores (a 11-item sleep quality assessment questionnaire) and Hospital Anxiety and Depression Scale (HADS) score, which quantifies levels of depression and anxiety using 14 questions."
Answered by AI
Is this research endeavor currently recruiting participants?
"The information on clinicaltrials.gov states that this investigation, which was first posted on March 12th 2021, is no longer enrolling patients. Despite its closure, there are currently 99 other trials recruiting participants."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Quebec
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
What site did they apply to?
Alan Edwards Pain Management Unit - Montreal General Hospital
Why did patients apply to this trial?
Went quickly over my medical history in the other box, but other than that I was diagnosed with depression as well, and had been on a citalopram, wellbutrin, hydroxychloroquin (when they suspected sjogren syndrome), cyclobenzaprine (that I took periodically for a while for intense muscle cramps).
PatientReceived 1 prior treatment
Went quickly over my medical history in the other box, but other than that I was diagnosed with depression as well, and had been on a citalopram, wellbutrin, hydroxychloroquin (when they suspected sjogren syndrome), cyclobenzaprine (that I took periodically for a while for intense muscle cramps). I’m now taking Trintellix for depression + pregabalin for nerve pain with little success.
PatientReceived 1 prior treatment
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