Trial | NCT02642289  Report issue

Official Title

Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
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 Started
Dec 31
2015
Primary Completion
Feb 29
2016
Study Completion
Feb 29
2016
Last Update
Mar 14
2016
Estimate

Dietary Supplement Lactobacillus acidophilus

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

Dietary Supplement Lactobacillus Rhamnosus GG ®

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

Other Placebo

Innocuous substance

Probiotic1: Lactobacillus acidophilus Experimental

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

Placebo Placebo Comparator

Inactivate substance

Probiotic2: Lactobacillus Rhamnosus GG ® Experimental

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

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).
No Results Posted