Clinical trial NCT04435886: Use of a Probiotic in the Treatment of Fibromyalgia (FIBROPROB)
Official title: A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Probiotic
Fibromyalgia
Lead sponsor: Biopolis S.L.
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 12-week randomized, double-blind, parallel-group, placebo-controlled study
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Score on the Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 4-week
measure: Score on the Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 8-week
measure: Score on the Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 12-week
Secondary outcomes:
measure: Score on the Hospital Anxiety and Depression Scale (HAD)
timeFrame: 4 weeks
measure: Score on the Hospital Anxiety and Depression Scale (HAD)
timeFrame: 8 weeks
measure: Score on the Hospital Anxiety and Depression Scale (HAD)
timeFrame: 12 weeks
measure: Visual Analogical Pain Scale (VAS) Score
timeFrame: 12 weeks
measure: Changes to a patient's usual medical treatment for fibromyalgia
timeFrame: 4 weeks
measure: Changes to a patient's usual medical treatment for fibromyalgia
timeFrame: 8 weeks
measure: Changes to a patient's usual medical treatment for fibromyalgia
timeFrame: 12 weeks
measure: Treatment adherence rate
timeFrame: 4 weeks
measure: Treatment adherence rate
timeFrame: 8 weeks
measure: Treatment adherence rate
timeFrame: 12 weeks
measure: Number of adverse events
timeFrame: 4 weeks
measure: Number of adverse events
timeFrame: 8 weeks
measure: Number of adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital Universitario de Vinalopó
state: Alicante
Study officials:
References: