Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB) (FIBROPROB)
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ClinicalTrials.gov Identifier: NCT04435886 |
Recruitment Status : Unknown
Verified June 2020 by Biopolis S.L..
Recruitment status was: Recruiting
First Posted : June 17, 2020
Last Update Posted : July 10, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | June 15, 2020 | ||||
First Posted Date ICMJE | June 17, 2020 | ||||
Last Update Posted Date | July 10, 2020 | ||||
Actual Study Start Date ICMJE | March 2, 2020 | ||||
Estimated Primary Completion Date | February 2, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB) | ||||
Official Title ICMJE | A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia | ||||
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 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 | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 12-week randomized, double-blind, parallel-group, placebo-controlled study Masking: Double (Participant, Investigator)Masking Description: Double-blind Primary Purpose: Treatment
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Condition ICMJE | Fibromyalgia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | May 2, 2021 | ||||
Estimated Primary Completion Date | February 2, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04435886 | ||||
Other Study ID Numbers ICMJE | FIBRO.PROB | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Biopolis S.L. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Biopolis S.L. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Biopolis S.L. | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |