Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

Study Overview
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Brief Summary
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This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.

Detailed Description
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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.

Official Title
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Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Dietary Supplement: Lactobacillus acidophilus
* Dietary Supplement: Lactobacillus Rhamnosus GG ®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fibromyalgia syndrome diagnosis. No treatment with antibiotic. More than a year of diagnosis Agreement to participate in the study. Exclusion Criteria: Severe physical disability. Malignancy. Pregnancy Psychiatric illnesses (eg, schizophrenia or substance abuse). Medication usage other than as-needed analgesics (excluding long-term narcotics).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic1: Lactobacillus acidophilus<br>Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions) | Dietary Supplement: Lactobacillus acidophilus<br>* Probiotic 5000, a commercial probiotic product provided by the company Complementos Fitonutricionales, S.L.<br>|
| Placebo Comparator: Placebo<br>Inactivate substance | Other: Placebo<br>* Innocuous substance<br>|
| Experimental: Probiotic2: Lactobacillus Rhamnosus GG ®<br>Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions) | Dietary Supplement: Lactobacillus Rhamnosus GG ®<br>* Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab Laboratorios Nutergia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Scores on Working memory and attentional control | Corsi task | Time Frame: At baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 (%) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics