A Prospective, Randomised, Controlled Crossover Study on the Effectiveness of Bifidobacterium Adolescentis PRL2019 in the Treatment of Juvenile Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the clinical effectiveness of Gabapral® in reducing musculoskeletal pain in paediatric patients with JFS.
研究概览
简要总结
Juvenile Fibromyalgia Syndrome (JFS) is a chronic condition affecting children and adolescents, characterised by widespread musculoskeletal pain and a significant impact on daily life and quality of life. Gastrointestinal symptoms and changes in gut microbiota have been reported in patients with fibromyalgia, suggesting a possible role of the gut-immune system interaction in the disease.
This study aims to investigate whether Gabapral®, a food supplement containing the probiotic strain Bifidobacterium adolescentis PRL2019, may help reduce pain symptoms and improve clinical outcomes in paediatric patients with JFS.
The hypothesis of this study is that modulation of the gut microbiota with Gabapral® may contribute to improvement of symptoms related to Juvenile Fibromyalgia Syndrome.
详细描述
Juvenile Fibromyalgia Syndrome (JFS) is a complex condition characterised by widespread pain, fatigue, and functional impairment. The pathophysiology of JFS is multifactorial, involving mechanisms related to central sensitisation, pain regulation, immune response, and possible alterations in the gut-brain axis.
The intestinal microbiota is involved in several physiological processes, including regulation of immune function, maintenance of intestinal barrier integrity, and production of bioactive metabolites that may influence communication between the gut and nervous system. Alterations in gut microbiota composition have been described in patients with fibromyalgia, and gastrointestinal symptoms are frequently observed in this population.
Gabapral® contains Bifidobacterium adolescentis PRL2019, a probiotic strain naturally found in the human intestinal microbiota. Bifidobacterium adolescentis has been associated with immunomodulatory properties and the production of gamma-aminobutyric acid (GABA), a metabolite involved in gut-brain communication. Preclinical studies have identified PRL2019 among strains with high GABA-producing capacity.
Previous studies have evaluated the safety and potential effects of Bifidobacterium adolescentis PRL2019 in paediatric patients with gastrointestinal disorders, including irritable bowel syndrome. However, its potential role in Juvenile Fibromyalgia Syndrome has not yet been explored.
This study is designed to investigate whether modulation of the gut microbiota through Gabapral® supplementation may influence clinical symptoms and biological pathways associated with JFS. Exploratory microbiota and metabolomic analyses will provide additional information regarding possible mechanisms underlying treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 9 and 25 years;
- •Written informed consent to participate in the study obtained prior to the start of the study from the patient or both parents/legal guardians of the patient if a minor, and the assent of the minor;
- •Diagnosis of JFS according to the 2010 American College of Rheumatology (ACR) criteria 15, with disease onset before 18 years of age;
- •Willingness to comply with follow-up visits and provide biological samples (blood and stool) according to the schedule defined in the protocol.
排除标准
- •any conditions that may affect the ability to complete informed consent;
- •denial of the informed consent;
- •presence of concomitant organic GI diseases, such as inflammatory bowel disease, celiac disease, eosinophilic or autoimmune gastroenteropathies, or history of major abdominal surgery;
- •acute infection at the time of recruitment;
- •antibiotic treatment within 3 months prior to recruitment;
- •use of any prebiotic, probiotic, or postbiotic in the previous 2 months before enrolment;
- •significant eating disorders, including diagnosed eating behaviour disorders.
结局指标
主要结局
To evaluate the clinical effectiveness of Gabapral® in reducing musculoskeletal pain in paediatric patients with JFS.
时间窗: From the start of each treatment period (baseline) to the end of the 12-week treatment period
Reduction in musculoskeletal pain intensity, measured by the 21-numbered circle Visual Analogue Scale (VAS)14, where 0 corresponds to "no pain" and 10 to "worst imaginable pain". Baseline is defined as the mean VAS scores recorded over the 7 days preceding the start of each treatment period (i.e. before Period 1 start and before crossover to Period 2). The treatment effect is calculated as the change from baseline to the mean VAS score recorded over the last 7 days of the treatment period. A patient will be defined as a responder if achieving a 3 2 points reduction in the weekly average VAS score from baseline. The VAS will be self-reported by all enrolled patients.
次要结局
- To assess changes in abdominal pain intensity following treatment with Gabapral®(Change from baseline to the end of each 12-week treatment period)
- To assess changes in fatigue intensity following treatment with Gabapral®(Change from baseline to the end of each 12-week treatment period)
- To assess changes in functional measures following treatment with Gabapral®(Change from baseline to the end of each 12-week treatment period)
- To assess changes in headache intensity following treatment with Gabapral®(From the start of each treatment period (baseline) to the end of the 12-week treatment period)
- To assess changes in global assessment of disease severity following treatment with Gabapral®(From the start of each treatment period (baseline) to the end of the 12-week treatment period)
- To assess changes in widespread pain following treatment with Gabapral®(From the start of each treatment period (baseline) to the end of the 12-week treatment period)
- To assess changes in symptom severity following treatment with Gabapral®(From the start of each treatment period (baseline) to the end of the 12-week treatment period)
- To assess changes in depressive symptoms following treatment with Gabapral®.(Change from baseline to the end of each 12-week treatment period)
- To assess changes in anxiety symptoms following treatment with Gabapral®(Change from baseline to the end of each 12-week treatment period)
- To characterise the composition of the gut microbiota in a cohort of JFS patients.(Baseline before Period 1 (Week 0), end of Treatment Period 1 (Week 12), baseline before Period 2 following washout (Week 18), and end of Treatment Period 2 (Week 30).)
- To examine the impact of Gabapral on gut microbiota composition and related metabolomic pathways.(Baseline (Week 0) and end of each 12-week treatment period (Week 12 and Week 30).)