Clinical trial NCT02642289: Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
Official title: Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Probiotics
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change Scores on Working memory and attentional control
timeFrame: Time Frame: At baseline and 8 weeks
Secondary outcomes:
measure: Change Scores on Body Composition
timeFrame: Time Frame: At baseline and 8 weeks
measure: Changes Scores on Cholinergic response indicators (%)
timeFrame: Time Frame: At baseline and 8 weeks
measure: Changes Scores on Heart rate variability.
timeFrame: Time Frame: At baseline and 8 weeks
measure: Changes Scores on Valsalva ratio. K30/15.
timeFrame: Time Frame: At baseline and 8 weeks
measure: Changes Scores on Systemic vascular resistance.
timeFrame: Time Frame: At baseline and 8 weeks
measure: Change Scores on Pain
timeFrame: Time Frame: At baseline and 8 weeks
measure: Change Scores on Sleep Quality
timeFrame: Time Frame: At baseline and 8 weeks
measure: Change Scores on Quality of Life
timeFrame: Time Frame: At baseline and 8 weeks
measure: Change Scores on Depression
timeFrame: Time Frame: At baseline and 8 weeks
measure: Change Scores on Stress
timeFrame: Time Frame: At baseline and 8 weeks
measure: Change Scores on Anxiety
timeFrame: Time Frame: At baseline and 8 weeks
measure: Change Scores on Impulsivity
timeFrame: Time Frame: At baseline and 8 weeks
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: Pablo Roman
Study officials:
affiliation: Universidad de Almeria
name: Angeles Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: