Probiotics for Cognitive Function, Pain, and Quality of Life in People With Fibromyalgia

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.

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.

Inclusion Criteria:

• Female participants aged 18 years or older.
• Diagnosis of fibromyalgia (severity grade 1-4) according to the American College of Rheumatology (ACR) criteria, established at least 1 year prior to enrollment.
• Body mass index (BMI) < 30 kg/m².
• Ability and willingness to provide written informed consent.

Exclusion Criteria:

• Pregnancy or breastfeeding.
• Use of probiotics within 6 months prior to study enrollment.
• Use of antibiotics within 6 months prior to study enrollment.
• History of inflammatory bowel disease.
• Pre-existing psychiatric disorder diagnosed prior to fibromyalgia diagnosis.
• Active cancer.
• History of gastrointestinal cancer.
• History of chemotherapy treatment.
• History of radiotherapy in the abdomino-pelvic region.
• Participation in another clinical trial.