Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Dietary Supplement: Lactobacillus acidophilus; Dietary Supplement: Lactobacillus Rhamnosus GG ®; Other: Placebo

• Registration Number: NCT02642289
• Lead Sponsor: Pablo Román López

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-24
• Study First Posted: 2015-12-30
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic1: Lactobacillus acidophilus	Lactobacillus acidophilus	Dietary Supplement: Probiotics 1. 8-week probiotic food-supplement intervention with Lactobacillus acidophilus (Daily intake: 24 millions)
Probiotic2: Lactobacillus Rhamnosus GG ®	Lactobacillus Rhamnosus GG ®	Dietary Supplement: Probiotics 2 8-week probiotic food-supplement intervention with Lactobacillus Rhamnosus (Daily intake: 24 millions)
Placebo	Placebo	Inactivate substance

Primary Outcome Measures

Name	Time	Method
Change Scores on Working memory and attentional control	Time Frame: At baseline and 8 weeks	Corsi task

Secondary Outcome Measures

Name	Time	Method
Changes Scores on Heart rate variability.	Time Frame: At baseline and 8 weeks
Changes Scores on Systemic vascular resistance.	Time Frame: At baseline and 8 weeks
Change Scores on Quality of Life	Time Frame: At baseline and 8 weeks	The assessment of Quality of Life (SF-36)
Change Scores on Stress	Time Frame: At baseline and 8 weeks	Determination of cortisol in urine
Change Scores on Sleep Quality	Time Frame: At baseline and 8 weeks	Pittsburgh Sleep Quality Index Questionnaire (PSQI)
Change Scores on Body Composition	Time Frame: At baseline and 8 weeks	Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.
Changes Scores on Valsalva ratio. K30/15.	Time Frame: At baseline and 8 weeks
Change Scores on Depression	Time Frame: At baseline and 8 weeks	The Beck inventory for depression
Change Scores on Anxiety	Time Frame: At baseline and 8 weeks	The State-Trait Anxiety Inventory (STAI)
Changes Scores on Cholinergic response indicators (%)	Time Frame: At baseline and 8 weeks
Change Scores on Pain	Time Frame: At baseline and 8 weeks	Index of Widespread Pain and Symptom Severity
Change Scores on Impulsivity	Time Frame: At baseline and 8 weeks	The Two-choice task

Trial Locations

Locations (1)

Pablo Roman; 🇪🇸 Almeria, Spain