NCT04435886

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

A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Biopolis S.L. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Probiotic mixture with maltodextrin as a carrier.
DIETARY_SUPPLEMENT	Placebo	Placebo comparator with maltodextrin as a carrier.

Timeline

• Start date: 2020-03-02
• Primary completion: 2021-02-02
• Completion: 2021-05-02
• First posted: 2020-06-17
• Last updated: 2020-07-10

Locations

1 site across 1 country: Spain