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

Launched by BIOPOLIS S.L. · Jun 15, 2020

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Eligibility criteria

• 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.
• • 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.