Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
1 other identifier
interventional
60
1 country
1
Brief Summary
This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
December 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 14, 2016
March 1, 2016
2 months
December 21, 2015
March 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change Scores on Working memory and attentional control
Corsi task
Time Frame: At baseline and 8 weeks
Secondary Outcomes (12)
Change Scores on Body Composition
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
- +7 more secondary outcomes
Study Arms (3)
Probiotic1: Lactobacillus acidophilus
EXPERIMENTALDietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions)
Placebo
PLACEBO COMPARATORInactivate substance
Probiotic2: Lactobacillus Rhamnosus GG ®
EXPERIMENTALDietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions)
Interventions
Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."
Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"
Eligibility Criteria
You may qualify if:
- Fibromyalgia syndrome diagnosis.
- No treatment with antibiotic.
- More than a year of diagnosis
- Agreement to participate in the study.
You may not qualify if:
- Severe physical disability.
- Malignancy.
- Pregnancy
- Psychiatric illnesses (eg, schizophrenia or substance abuse).
- Medication usage other than as-needed analgesics (excluding long-term narcotics).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pablo Roman
Almería, Almeria, 04120, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angeles Fernandez, PhD
Universidad de Almeria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
December 21, 2015
First Posted
December 30, 2015
Study Start
December 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
March 14, 2016
Record last verified: 2016-03