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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | A multi-strain probiotic |
|
| Placebo group | Placebo Comparator | Identical placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotic mixture with maltodextrin as a carrier. |
| |
| 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 |
| 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 |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María Empar Chenoll, PhD | Contact | +34 673 53 53 44 | maria.chenoll@adm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Vinalopó | Recruiting | Elche | Alicante | 03293 | Spain |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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12-week randomized, double-blind, parallel-group, placebo-controlled study
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Double-blind
| Placebo |
| Dietary Supplement |
Placebo comparator with maltodextrin as a carrier. |
|
| 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 |
| D009422 |
| Nervous System Diseases |
| D019602 |
| Food and Beverages |