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This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
Probiotics has demonstrated to be effective in the management of anxiety and depression. Although these results are promising, more research is needed to explore the role of probiotics to improve physical, emotional and cognitive processes in different clinical populations that are associated with altered microbiome. Thus, the main aim of the present project is to explore whether the oral intake of probiotics might provide benefits to a group of patients with fibromyalgia.
The investigators expect to found significant differences between some physical, emotional and cognitive measures assessed pre- and post-treatment demonstrating the effects of microbiota on the Central Nervous System as well as its potential as a therapeutic tool for the treatment of Fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic1: Lactobacillus acidophilus | Experimental | Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions) |
|
| Placebo | Placebo Comparator | Inactivate substance |
|
| Probiotic2: Lactobacillus Rhamnosus GG ® | Experimental | Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus acidophilus | Dietary Supplement | Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L." |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change Scores on Working memory and attentional control | Corsi task | Time Frame: At baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change Scores on Body Composition | Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water. | Time Frame: At baseline and 8 weeks |
| Changes Scores on Cholinergic response indicators (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angeles Fernandez, PhD | Universidad de Almeria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pablo Roman | Almería | Almeria | 04120 | 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 |
|---|---|
| C100843 | Lacteol |
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| Lactobacillus Rhamnosus GG ® | Dietary Supplement | Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia" |
|
| Placebo | Other | Innocuous substance |
|
| Time Frame: At baseline and 8 weeks |
| Changes Scores on Heart rate variability. | Time Frame: At baseline and 8 weeks |
| Changes Scores on Valsalva ratio. K30/15. | Time Frame: At baseline and 8 weeks |
| Changes Scores on Systemic vascular resistance. | Time Frame: At baseline and 8 weeks |
| Change Scores on Pain | Index of Widespread Pain and Symptom Severity | Time Frame: At baseline and 8 weeks |
| Change Scores on Sleep Quality | Pittsburgh Sleep Quality Index Questionnaire (PSQI) | Time Frame: At baseline and 8 weeks |
| Change Scores on Quality of Life | The assessment of Quality of Life (SF-36) | Time Frame: At baseline and 8 weeks |
| Change Scores on Depression | The Beck inventory for depression | Time Frame: At baseline and 8 weeks |
| Change Scores on Stress | Determination of cortisol in urine | Time Frame: At baseline and 8 weeks |
| Change Scores on Anxiety | The State-Trait Anxiety Inventory (STAI) | Time Frame: At baseline and 8 weeks |
| Change Scores on Impulsivity | The Two-choice task | Time Frame: At baseline and 8 weeks |
| D009422 |
| Nervous System Diseases |