Status:
UNKNOWN
Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)
Lead Sponsor:
Biopolis S.L.
Conditions:
Fibromyalgia
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief 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 tre...
Eligibility Criteria
Inclusion
- Age between 20 - 65 years.
- Signature of informed consent by the patient.
- Patients diagnosed according to the 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia
Exclusion
- 11\. Women who are pregnant, breastfeeding or who do not commit to using an effective method of 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. 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.
- 7\. 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.
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 2 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04435886
Start Date
March 2 2020
End Date
May 2 2021
Last Update
July 10 2020
Active Locations (1)
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1
Hospital Universitario de Vinalopó
Elche, Alicante, Spain, 03293