Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of children with intestinal dysbiosis after 6 months of treatment.
研究概览
简要总结
Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.
An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.
The duration of the study will be of 6 months approximately, including 6 months of product intake.
Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 7 years old.
- •Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification.
- •Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).
- •Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.
排除标准
- •With intake of antibiotics in the last month.
- •With intake of probiotics in the last two weeks.
- •Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.
- •Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).
- •Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc.
- •Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
- •Congenital or acquired immunodeficiency.
- •Immunocompromised (e.g., cancer and/or transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system).
- •Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol.
- •With oral hyper sensitivity impairments that prevent the uptake of the study product.
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Probiotic
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Number of children with intestinal dysbiosis after 6 months of treatment.
时间窗: After 6 months of intervention.
次要结局
未报告次要终点