Fibromyalgia
Conditions
Keywords
Probiotics
Brief summary
This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus acidophilus
Probiotic 5000, a commercial probiotic product provided by the company Complementos Fitonutricionales, S.L.
DIETARY_SUPPLEMENTLactobacillus Rhamnosus GG ®
Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab Laboratorios Nutergia
OTHERPlacebo
Innocuous substance
Sponsors
Pablo Román López
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change Scores on Working memory and attentional control | Time Frame: At baseline and 8 weeks | Corsi task |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Time Frame: At baseline and 8 weeks | Index of Widespread Pain and Symptom Severity |
| Change Scores on Body Composition | Time Frame: At baseline and 8 weeks | Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water. |
| Change Scores on Quality of Life | Time Frame: At baseline and 8 weeks | The assessment of Quality of Life (SF-36) |
| Change Scores on Depression | Time Frame: At baseline and 8 weeks | The Beck inventory for depression |
| Change Scores on Stress | Time Frame: At baseline and 8 weeks | Determination of cortisol in urine |
| Change Scores on Anxiety | Time Frame: At baseline and 8 weeks | The State-Trait Anxiety Inventory (STAI) |
| Change Scores on Impulsivity | Time Frame: At baseline and 8 weeks | The Two-choice task |
| Change Scores on Sleep Quality | Time Frame: At baseline and 8 weeks | Pittsburgh Sleep Quality Index Questionnaire (PSQI) |
Countries
Spain
Outcome results
None listed