Fibromyalgia
Conditions
Keywords
Probiotic, 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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic mixture with maltodextrin as a carrier.
DIETARY_SUPPLEMENTPlacebo
Placebo comparator with maltodextrin as a carrier.
Sponsors
Biopolis S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
12-week randomized, double-blind, parallel-group, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Fibromyalgia Impact Questionnaire (FIQ) | 4-week | Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score on the Hospital Anxiety and Depression Scale (HAD) | 4 weeks | Score on the Hospital Anxiety and Depression Scale (HAD), To determine the levels of anxiety and depression that a person is experiencing. It is a fourteen item scale; seven items are related to anxiety and seven to depression. Each item is scored from 0-3, being the total score from 0 to 21 for either anxiety or depression. The higher score the worse state. in weeks 4 |
| Visual Analogical Pain Scale (VAS) Score | 12 weeks | Visual Analogical Pain Scale (VAS) Score. It is a unidimensional continuous measure of pain intensity. It comprises a horizontal (HVAS) or vertical (VVAS) line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 \[100-mm scale\]). in weeks 12 |
| Changes to a patient's usual medical treatment for fibromyalgia | 4 weeks | Changes to a patient's usual medical treatment for fibromyalgia, in weeks 4 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78) |
| Treatment adherence rate | 4 weeks | Treatment adherence rate using the returned capsules, in weeks 4 |
| Number of adverse events | 4 weeks | Numbre od adverse effects reported, 4 weeks |
Countries
Spain
Contacts
Primary ContactMaría Empar Chenoll, PhD
Outcome results
None listed