Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)
NCT ID: NCT04435886
Last Updated: 2020-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-03-02
2021-05-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probiotic group
A multi-strain probiotic
Probiotic
Probiotic mixture with maltodextrin as a carrier.
Placebo group
Identical placebo
Placebo
Placebo comparator with maltodextrin as a carrier.
Interventions
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Probiotic
Probiotic mixture with maltodextrin as a carrier.
Placebo
Placebo comparator with maltodextrin as a carrier.
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
65 Years
ALL
No
Sponsors
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Biopolis S.L.
INDUSTRY
Responsible Party
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Locations
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Hospital Universitario de Vinalopó
Elche, Alicante, Spain
Countries
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Central Contacts
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Facility Contacts
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Maria Victoria Soto Borrás
Role: primary
Other Identifiers
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FIBRO.PROB
Identifier Type: -
Identifier Source: org_study_id
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