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Completed

NCT Number: NCT02642289

Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pablo Roman

Almería, Almeria, 04120, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lactobacillus acidophilus

Dietary Supplement

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

Lactobacillus Rhamnosus GG ®

Dietary Supplement

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

Placebo

Other

Innocuous substance

Primary outcomes

  1. Change Scores on Working memory and attentional control

    Time frame: Time Frame: At baseline and 8 weeks

    Corsi task

Secondary outcomes

  1. Change Scores on Body Composition

    Time frame: Time Frame: At baseline and 8 weeks

    Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.

  2. Changes Scores on Cholinergic response indicators (%)

    Time frame: Time Frame: At baseline and 8 weeks

  3. Changes Scores on Heart rate variability.

    Time frame: Time Frame: At baseline and 8 weeks

  4. Changes Scores on Valsalva ratio. K30/15.

    Time frame: Time Frame: At baseline and 8 weeks

  5. Changes Scores on Systemic vascular resistance.

    Time frame: Time Frame: At baseline and 8 weeks

  6. Change Scores on Pain

    Time frame: Time Frame: At baseline and 8 weeks

    Index of Widespread Pain and Symptom Severity

  7. Change Scores on Sleep Quality

    Time frame: Time Frame: At baseline and 8 weeks

    Pittsburgh Sleep Quality Index Questionnaire (PSQI)

  8. Change Scores on Quality of Life

    Time frame: Time Frame: At baseline and 8 weeks

    The assessment of Quality of Life (SF-36)

  9. Change Scores on Depression

    Time frame: Time Frame: At baseline and 8 weeks

    The Beck inventory for depression

  10. Change Scores on Stress

    Time frame: Time Frame: At baseline and 8 weeks

    Determination of cortisol in urine

  11. Change Scores on Anxiety

    Time frame: Time Frame: At baseline and 8 weeks

    The State-Trait Anxiety Inventory (STAI)

  12. Change Scores on Impulsivity

    Time frame: Time Frame: At baseline and 8 weeks

    The Two-choice task

Sponsors and collaborators

Lead sponsor

Pablo Román López

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 30, 2015
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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