Pablo Roman
Almería, Almeria, 04120, Spain
NCT Number: NCT02642289
This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Almería, Almeria, 04120, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."
Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"
Innocuous substance
Time frame: Time Frame: At baseline and 8 weeks
Corsi task
Time frame: Time Frame: At baseline and 8 weeks
Fat mass. Body fat mass. Intracellular water. Extracellular water. Fat-free mass. Total body water.
Time frame: Time Frame: At baseline and 8 weeks
Time frame: Time Frame: At baseline and 8 weeks
Time frame: Time Frame: At baseline and 8 weeks
Time frame: Time Frame: At baseline and 8 weeks
Time frame: Time Frame: At baseline and 8 weeks
Index of Widespread Pain and Symptom Severity
Time frame: Time Frame: At baseline and 8 weeks
Pittsburgh Sleep Quality Index Questionnaire (PSQI)
Time frame: Time Frame: At baseline and 8 weeks
The assessment of Quality of Life (SF-36)
Time frame: Time Frame: At baseline and 8 weeks
The Beck inventory for depression
Time frame: Time Frame: At baseline and 8 weeks
Determination of cortisol in urine
Time frame: Time Frame: At baseline and 8 weeks
The State-Trait Anxiety Inventory (STAI)
Time frame: Time Frame: At baseline and 8 weeks
The Two-choice task
Pablo Román López
Other
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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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