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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

Must not have

Any major illness (e.g. malignancy, active inflammatory disease, metabolic disease, etc.)

Inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four weeks after the initiation of the new diet compared to baseline.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I experience widespread pain almost all the time.

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I am a woman over 18 diagnosed with fibromyalgia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major illnesses like cancer or metabolic diseases.

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I have inflammatory bowel disease.

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I have severe depression.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks after the initiation of the new diet compared to baseline. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Hospital Anxiety and Depression Scale (HADS) score

ROME IV criteria for irritable bowel syndrome

The Fibromyalgia Impact Questionnaire (FIQ) score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Low-FODMAP diet

2016

N/A

~40