Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)

Biopolis

Status: Unknown

Conditions: Fibromyalgia

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04435886

FIBRO.PROB

Details and patient eligibility

About

This study aims to understand the efficacy of two probiotic interventions as prophylaxes of fibromyalgia symptoms in individuals diagnosed.

The primary outcome measure will be the progression and treatment of fibromyalgia, defined as a decrease in the Fibromyalgia Impact Questionnaire (FIQ) score, other otucomes will be the effect on the symptoms of anxiety and depression associated with fibromyalgia, defined as a decrease in the Hospital Anxiety and Depression Scale (HAD) score; perception of pain by scoring on a Visual Analogical Pain Scale (VAS), and differences in the patient's usual medical treatment. Finally adverse effects will be evaluated.

The study will have two arms: one arm including a probiotic preparation and a placebo arm.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 20 - 65 years.
2. Signature of informed consent by the patient.
3. Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia

Exclusion criteria

11. Women who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.

12. Known allergy to any of the components of the study product or the placebo. 3. Consumption of antibiotics in the 2 weeks prior to the start of the study. 4. Consumption of probiotics in the 2 months prior to the start of the study. 5. Evidence of neuropsychiatric disorders including: Parkinson's disease, psychotic disorder, bipolar depression 6. Regular consumption of alcohol in excess of 45 g ethanol/day in the year prior to study inclusion.

13. Any concurrent malignant pathology known at the time of inclusion in the study or serious metabolic, cardiovascular, renal, hepatic or gastrointestinal diseases which may lead to non-completion of the study according to the investigator's criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

A multi-strain probiotic

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

Identical placebo

Treatment:

Dietary Supplement: Placebo