Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

NCT ID: NCT02642289

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-02-29

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic1: Lactobacillus acidophilus

Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions)

Group Type: EXPERIMENTAL

Lactobacillus acidophilus

Intervention Type: DIETARY_SUPPLEMENT

Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."

Placebo

Inactivate substance

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Innocuous substance

Probiotic2: Lactobacillus Rhamnosus GG ®

Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions)

Group Type: EXPERIMENTAL

Lactobacillus Rhamnosus GG ®

Intervention Type: DIETARY_SUPPLEMENT

Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"

Interventions

Lactobacillus acidophilus

Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."

Intervention Type: DIETARY_SUPPLEMENT

Lactobacillus Rhamnosus GG ®

Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Innocuous substance

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pablo Román López

OTHER

Sponsor Role: lead

Responsible Party

Pablo Román López

PhD Student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Angeles Fernandez, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Almeria

Locations

Pablo Roman

Almería, Almeria, Spain

Countries

Spain

Other Identifiers

UAL-270415

Identifier Type: -

Identifier Source: org_study_id