Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642289
• Other study ID #: UAL-270415
• Status: Completed
• Phase: N/A
• First received: December 21, 2015
• Last updated: March 11, 2016
• Start date: December 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• Lactobacillus acidophilus
Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."
• Lactobacillus Rhamnosus GG ®
Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"

Other:
• Placebo
Innocuous substance

Locations

Country	Name	City	State
Spain	Pablo Roman	Almeria

Sponsors (1)

Lead Sponsor	Collaborator
Pablo Román López

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Scores on Working memory and attentional control	Corsi task	Time Frame: At baseline and 8 weeks	No
Secondary	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	No
Secondary	Changes Scores on Cholinergic response indicators (%)		Time Frame: At baseline and 8 weeks	No
Secondary	Changes Scores on Heart rate variability.		Time Frame: At baseline and 8 weeks	No
Secondary	Changes Scores on Valsalva ratio. K30/15.		Time Frame: At baseline and 8 weeks	No
Secondary	Changes Scores on Systemic vascular resistance.		Time Frame: At baseline and 8 weeks	No
Secondary	Change Scores on Pain	Index of Widespread Pain and Symptom Severity	Time Frame: At baseline and 8 weeks	No
Secondary	Change Scores on Sleep Quality	Pittsburgh Sleep Quality Index Questionnaire (PSQI)	Time Frame: At baseline and 8 weeks	No
Secondary	Change Scores on Quality of Life	The assessment of Quality of Life (SF-36)	Time Frame: At baseline and 8 weeks	No
Secondary	Change Scores on Depression	The Beck inventory for depression	Time Frame: At baseline and 8 weeks	No
Secondary	Change Scores on Stress	Determination of cortisol in urine	Time Frame: At baseline and 8 weeks	No
Secondary	Change Scores on Anxiety	The State-Trait Anxiety Inventory (STAI)	Time Frame: At baseline and 8 weeks	No
Secondary	Change Scores on Impulsivity	The Two-choice task	Time Frame: At baseline and 8 weeks	No