Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia

Study Overview
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Brief Summary
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The study evaluated the efficacy and tolerability of probiotic VSL#3 for the treatment of gastrointestinal symptoms in patients with fibromyalgia; 50% of the participants received probiotic and the remaining 50% received matching placebo in a double-blind, randomized design.The treatment was administered during a 12-week period and the participants were followed for an additional 12-week period in order to follow the evolution after treatment.

Detailed Description
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Many patients with fibromyalgia experience associated gastrointestinal symptomatology such as abdominal pain, abdominal bloating, meteorism, diarrhea and/or constipation. To date there is not any specific treatment for these symptoms that markedly impair the quality of life of these subjects. This trial intended to investigate if the addition of a polymicrobial probiotic product, which has shown efficacy in patients with irritable bowel syndrome, was also be useful to ameliorate the gastrointestinal symptomatology of patients with fibromyalgia.

Official Title
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Efficacy and Tolerability of the Probiotic VSL#3 for the Treatment of Patients With Fibromyalgia and Associated Gastrointestinal Symptomatology: a Randomized, Double-blind Clinical Trial

Conditions
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Fibromyalgia, Gastrointestinal Disease

Intervention / Treatment
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* Dietary Supplement: VSL#3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed of fibromyalagia experiencing at least 3 chronic gastrointestinal symptoms signed informed consent to participate accept to not change previously prescribed treatment during study duration Exclusion Criteria: mental illness excepting depression severe organic disease additional gastrointestinal disease excepting irritable bowel syndrome pregnancy breastfeeding

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSL#3<br>probiotic VSL#3, 2 sachets b.i.d for 3 months | Dietary Supplement: VSL#3<br>* sachets containing probiotic<br>|
| Placebo Comparator: placebo<br>matched placebo, 2 sachets b.i.d for 3 months | Dietary Supplement: Placebo<br>* sachets containing placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change, From Baseline to Endpoint (12 Weeks) in the Composite Score of Abdominal Pain, Abdominal Bloating and Metheorism Each One Measured in a 0-10 Visual Analog Scale | Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 12 score - baseline score) | baseline and twelve weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR) | The FIQR is a self-reported, validated questionnaire that evaluates the severity of fibromyalgia symptomatology in a scale ranging from 0 to 100 points; the higher the score, the worse the severity of the disease. Change = (week 12 score - baseline score) | baseline and twelve weeks after treatment | 
| Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI) | The ISI is a self-reported, validated questionnaire that measures the severity of sleep disturbances in a scale ranging from 0 to 28 points: higher scores indicate more severe sleep disturbance | baseline and twelve weeks after treatment | 
| Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9) | PHQ-9 is a self-reported, validated questionnaire that measures the severity of depression in a scale ranging from 0 to 27 points; higher scores indicate more severe depression. Change = (week 12 score - baseline score) | baseline and twelve weeks after treatment | 
| Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS | The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score). | baseline and twelve weeks after treatment | 
| Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS | The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score). | baseline and 12 weeks after treatment | 
| Number of Patients Considered as Responders to Treatment | Patients that showed at least a a 30% reduction in the score of the primary variable, i.e. the composite ccore of abdominal pain, abdominal bloating and metheorism each one measured in a 0-10 Visual Analog Scale, were considered as responders to treatment. | Baseline and 12 weeks after treatment | 
| Change From Week 12 to Week 16 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment | Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 16 score - week 12 score) | Week 12 to week 16 | 
| Change From Week 12 to Week 20 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment | Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 20 score - week 12 score) | Week 12 to week 20 | 
| Change From Week 12 to Week 24 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment | Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 24 score - week 12 score) | Week 12 to week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, efficacy, tolerability