Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Dietary supplement: Lactobacillus acidophilus; Other: Placebo; Dietary supplement: Lactobacillus Rhamnosus GG ®

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Almeria, Spain, 04120
    • Pablo Roman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic1: Lactobacillus acidophilus; Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions)	Dietary supplement: Lactobacillus acidophilus; Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."
Placebo Comparator: Placebo; Inactivate substance	Other: Placebo; Innocuous substance
Experimental: Probiotic2: Lactobacillus Rhamnosus GG ®; Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions)	Dietary supplement: Lactobacillus Rhamnosus GG ®; Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Scores on Working memory and attentional control	Corsi task	Time Frame: At baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Scores on Body Composition	Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.	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
Change Scores on Pain	Index of Widespread Pain and Symptom Severity	Time Frame: At baseline and 8 weeks
Change Scores on Sleep Quality	Pittsburgh Sleep Quality Index Questionnaire (PSQI)	Time Frame: At baseline and 8 weeks
Change Scores on Quality of Life	The assessment of Quality of Life (SF-36)	Time Frame: At baseline and 8 weeks
Change Scores on Depression	The Beck inventory for depression	Time Frame: At baseline and 8 weeks
Change Scores on Stress	Determination of cortisol in urine	Time Frame: At baseline and 8 weeks
Change Scores on Anxiety	The State-Trait Anxiety Inventory (STAI)	Time Frame: At baseline and 8 weeks
Change Scores on Impulsivity	The Two-choice task	Time Frame: At baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Pablo Román López
• Investigators: Principal Investigator: Angeles Fernandez, PhD, Universidad de Almeria

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: December 24, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 11, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Probiotics
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: UAL-270415