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

Study Overview
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Brief Summary
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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.

Official Title
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A 12-weeks Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic in the Treatment of Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 - 65 years. Signature of informed consent by the patient. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 12-week randomized, double-blind, parallel-group, placebo-controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>A multi-strain probiotic | Dietary Supplement: Probiotic<br>* Probiotic mixture with maltodextrin as a carrier.<br>|
| Placebo Comparator: Placebo group<br>Identical placebo | Dietary Supplement: Placebo<br>* Placebo comparator with maltodextrin as a carrier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Fibromyalgia Impact Questionnaire (FIQ) | Score on the Fibromyalgia Impact Questionnaire (FIQ) in weeks 4 | 4-week | 
| Score on the Fibromyalgia Impact Questionnaire (FIQ) | Score on the Fibromyalgia Impact Questionnaire (FIQ), The score range is form 0 to 100, where each question has an score from 0 to 10. Higher scores refers a higher impact of fybromialgia in lifestile where 0 is the best functional capacity and higher quality of life and 100 the worst stat, in weeks 8 | 8-week | 
| Score on the Fibromyalgia Impact Questionnaire (FIQ) | Score on the Fibromyalgia Impact Questionnaire (FIQ), The score range is form 0 to 100, where each question has an score from 0 to 10. Higher scores refers a higher impact of fybromialgia in lifestile where 0 is the best functional capacity and higher quality of life and 100 the worst stat, in weeks 12. | 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on the Hospital Anxiety and Depression Scale (HAD) | 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 | 4 weeks | 
| Score on the Hospital Anxiety and Depression Scale (HAD) | 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 8 | 8 weeks | 
| Score on the Hospital Anxiety and Depression Scale (HAD) | 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 12. | 12 weeks | 
| Visual Analogical Pain Scale (VAS) Score | 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 | 12 weeks | 
| Changes to a patient's usual medical treatment for fibromyalgia | 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) | 4 weeks | 
| Changes to a patient's usual medical treatment for fibromyalgia | Changes to a patient's usual medical treatment for fibromyalgia, in weeks 8 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78) | 8 weeks | 
| Changes to a patient's usual medical treatment for fibromyalgia | Changes to a patient's usual medical treatment for fibromyalgia, in weeks 12 Little or no impact (46 or less) Some impact (50 -55) Substantial impact (56-59) Severe impact (60-78) | 12 weeks | 
| Treatment adherence rate | Treatment adherence rate using the returned capsules, in weeks 4 | 4 weeks | 
| Treatment adherence rate | Treatment adherence rate using the returned capsules, in weeks 8 | 8 weeks | 
| Treatment adherence rate | Treatment adherence rate using the returned capsules, in weeks 12 | 12 weeks | 
| Number of adverse events | Numbre od adverse effects reported, 4 weeks | 4 weeks | 
| Number of adverse events | Numbre od adverse effects reported, 8 weeks | 8 weeks | 
| Number of adverse events | Numbre od adverse effects reported, 12 weeks | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Fibromyalgia