Pathogenesis of Pediatric Obsessive-compulsive Disorder: Based on the Microbiota-gut-brain Axis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Changes in the diversity and composition of the microbiome before and after drug treatment.
研究概览
简要总结
This study aims to investigate the characteristics of the microbiota-gut-brain axis in pediatric patients with obsessive-compulsive disorder (OCD) through performing an integrated analysis of gut microbiota, serum metabolomics, neuroimaging and electroencephalography (EEG), conducted before and after treatment with selective serotonin reuptake inhibitors (SSRIs). The results will be compared with those of pediatric OCD paitents comorbid with tic disorder (TD) and healthy controls. The findings are expected to further elucidate the potential pathogenesis of OCD, providing a theoretical basis for identifying novel clinical intervention targets and optimizing treatment strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •We recruited outpatient children and adolescents with OCD confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (4th edition). The following inclusion and
排除标准
- •were also applied:
- •Inclusion Criteria:
- •(1) 7-17 years old, (2) Y-BOCS score ≥16, (3) with or without a history of TD, (4) Drug-naïve or drug-free for 8 weeks, (5) Wechsler IQ score ≥
- •Exclusion Criteria:
- •History of serious medical, neurological illness or other psychotic disorders other than OCD (tic disorder excepted).
- •Previous exposure to cognitive behavioral therapy (CBT) for OCD or TD.
- •serious suicide risk.
- •Has taken antibiotics, probiotics, prebiotics, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or immunosuppressants within the past 8 weeks.
- •Has a history of gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, constipation, hemorrhoids, or a history of gastrointestinal surgery, or has a history of autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus.
- •Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
研究组 & 干预措施
pediatric OCD patients
Drug-naïve or drug-free pediatric patients with OCD will be enrolled in this group. After data collection, they will receive treatment with SSRIs.
pediatric OCD patients comorbid with TD
Drug-naïve or drug-free pediatric OCD patients comorbid with TD will be enrolled in this group. After data collection, they will receive treatment with SSRIs and antipsychotics.
healthy controls
Healthy children and adolescents will be enrolled in this group for data collection.
结局指标
主要结局
Changes in the diversity and composition of the microbiome before and after drug treatment.
时间窗: Before and after treatment with SSRIs for 12 weeks
The diversity (including alpha-diversity and beta-diversity) and composition will be measured in OCD patients and OCD patients with TD before and after drug treatment, and the results will be compared with those of healthy controls.
次要结局
未报告次要终点
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center