Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lactobacillus acidophilus
Lactobacillus Rhamnosus GG ®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Probiotics
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).
Sites / Locations
- Pablo Roman
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Probiotic1: Lactobacillus acidophilus
Placebo
Probiotic2: Lactobacillus Rhamnosus GG ®
Arm Description
Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions)
Inactivate substance
Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions)
Outcomes
Primary Outcome Measures
Change Scores on Working memory and attentional control
Corsi task
Secondary Outcome Measures
Change Scores on Body Composition
Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.
Changes Scores on Cholinergic response indicators (%)
Changes Scores on Heart rate variability.
Changes Scores on Valsalva ratio. K30/15.
Changes Scores on Systemic vascular resistance.
Change Scores on Pain
Index of Widespread Pain and Symptom Severity
Change Scores on Sleep Quality
Pittsburgh Sleep Quality Index Questionnaire (PSQI)
Change Scores on Quality of Life
The assessment of Quality of Life (SF-36)
Change Scores on Depression
The Beck inventory for depression
Change Scores on Stress
Determination of cortisol in urine
Change Scores on Anxiety
The State-Trait Anxiety Inventory (STAI)
Change Scores on Impulsivity
The Two-choice task
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02642289
Brief Title
Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
Official Title
Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pablo Román López
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic1: Lactobacillus acidophilus
Arm Type
Experimental
Arm Description
Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactivate substance
Arm Title
Probiotic2: Lactobacillus Rhamnosus GG ®
Arm Type
Experimental
Arm Description
Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus acidophilus
Intervention Description
Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus Rhamnosus GG ®
Intervention Description
Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Innocuous substance
Primary Outcome Measure Information:
Title
Change Scores on Working memory and attentional control
Description
Corsi task
Time Frame
Time Frame: At baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change Scores on Body Composition
Description
Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.
Time Frame
Time Frame: At baseline and 8 weeks
Title
Changes Scores on Cholinergic response indicators (%)
Time Frame
Time Frame: At baseline and 8 weeks
Title
Changes Scores on Heart rate variability.
Time Frame
Time Frame: At baseline and 8 weeks
Title
Changes Scores on Valsalva ratio. K30/15.
Time Frame
Time Frame: At baseline and 8 weeks
Title
Changes Scores on Systemic vascular resistance.
Time Frame
Time Frame: At baseline and 8 weeks
Title
Change Scores on Pain
Description
Index of Widespread Pain and Symptom Severity
Time Frame
Time Frame: At baseline and 8 weeks
Title
Change Scores on Sleep Quality
Description
Pittsburgh Sleep Quality Index Questionnaire (PSQI)
Time Frame
Time Frame: At baseline and 8 weeks
Title
Change Scores on Quality of Life
Description
The assessment of Quality of Life (SF-36)
Time Frame
Time Frame: At baseline and 8 weeks
Title
Change Scores on Depression
Description
The Beck inventory for depression
Time Frame
Time Frame: At baseline and 8 weeks
Title
Change Scores on Stress
Description
Determination of cortisol in urine
Time Frame
Time Frame: At baseline and 8 weeks
Title
Change Scores on Anxiety
Description
The State-Trait Anxiety Inventory (STAI)
Time Frame
Time Frame: At baseline and 8 weeks
Title
Change Scores on Impulsivity
Description
The Two-choice task
Time Frame
Time Frame: At baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeles Fernandez, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pablo Roman
City
Almeria
ZIP/Postal Code
04120
Country
Spain
12. IPD Sharing Statement
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Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
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