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Probiotics for Cognitive Function, Pain, and Quality of Life in People With Fibromyalgia
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Summary
Fibromyalgia is a complex chronic disorder in which emerging evidence suggests a relevant role of the gut microbiota in modulating physiological processes through the gut-brain axis. In this context, probiotics have been proposed as a potential therapeutic strategy for symptom management in fibromyalgia. This study aimed to evaluate the effects of a multispecies probiotic formulation administered over 12 weeks on pain and fatigue in patients with fibromyalgia. Secondary outcomes included sleep disturbances, cognitive function, and emotional symptoms. This was a quadruple-blinded, randomized, placebo-controlled clinical trial. Participants were randomly assigned to receive either a daily capsule of a multispecies probiotic (Teoliance HPi10, Therascience) containing Lactobacillus acidophilus LA-3, Lactobacillus rhamnosus GG, Bifidobacterium BS01, Lactobacillus plantarum BG112, Streptococcus thermophilus SP4, Lactobacillus casei LCO3, and Lactobacillus reuteri LR92, or placebo, for 12 weeks. Clinical outcomes were assessed using validated questionnaires including VAS, BPI, SF-36, MOS, HADS, and FIQ.
Official title: Estudio Piloto, Prospectivo, Randomizado, Doble Ciego Para Estudiar el Efecto Sobre función Cognitiva, Dolor y Calidad de Vida de un Tratamiento Con probióticos en Pacientes Con Fibromialgia.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
97
Start Date
2020-11-27
Completion Date
2023-10-31
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
Multispecies Probiotic (Teoliance HPi10)
Participants receive a daily oral capsule of a multispecies probiotic formulation (Teoliance HPi10, Therascience) for 12 weeks. Each capsule contains Lactobacillus acidophilus LA-3, Lactobacillus rhamnosus GG, Bifidobacterium animalis subsp. lactis BS01, Lactobacillus plantarum BG112, Streptococcus thermophilus SP4, Lactobacillus casei LCO3, and Lactobacillus reuteri LR92 (approximately 10⁹ CFU per capsule). The intervention is administered once daily.
Placebo
Participants receive a matching placebo capsule identical in appearance to the active product but without active probiotic strains, administered orally once daily for 12 weeks.
Locations (1)
Hospital de Sant Pau
Barcelona, Spain