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

McGill University

Status: Active, not recruiting

Conditions: Fibromyalgia; Diet, Gluten-Free

Treatments: Behavioral: Gluten-free Diet; Behavioral: Low-FODMAP diet; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05329571

Diet-FM/2020-6134

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Low-FODMAP Diet

Experimental group

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).

Treatment:

Behavioral: Low-FODMAP diet

Gluten-Free Diet

Experimental group

Description:

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

Treatment:

Behavioral: Gluten-free Diet

Control

Other group

Description:

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

Treatment:

Behavioral: Control group