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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Irene Fernánde Castaño
Senior Consultant Physician, PhD, Principal Investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau