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

Last updated: July 8, 2020
Sponsor: Biopolis S.L.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

N/A

Clinical Study ID

NCT04435886
FIBRO.PROB
  • Ages 20-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

  2. 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. Consumptionof probiotics in the 2 months prior to the start of the study. 5. Evidence ofneuropsychiatric disorders including: Parkinson's disease, psychotic disorder, bipolardepression 6. Regular consumption of alcohol in excess of 45 g ethanol/day in the yearprior to study inclusion.

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

Study Design

Total Participants: 50
Study Start date:
March 02, 2020
Estimated Completion Date:
May 02, 2021

Connect with a study center

  • Hospital Universitario de Vinalopó

    Elche, Alicante 03293
    Spain

    Active - Recruiting

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