Longitudinal Study of Gut Microbiome in Obsessive-Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Alpha diversity
研究概览
简要总结
Background: Humans live in symbiosis with microbes and their implication for health and disease is evident. The importance of microbiome-gut-brain axis in psychiatric disorders is an area of increasing research interest. OCD is a promising target for microbiome research as Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/ Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) are reactions to infectious agents precipitating acute onset of severe OCD symptoms. Furthermore, preliminary evidence has associated probiotic treatment with alleviation of OCD symptoms. We propose the first clinical study on the microbiome and its effects on OCD patients.
Aim: To analyze the gut microbiota in patients with OCD compared with healthy matched controls and assess changes in microbial composition following treatment.
Outcome measures: Differences in alpha diversity, beta diversity, and taxa abundance of bacterial groups (at the phylum, class, order, family, genus and species levels) and severity of OCD symptoms. Moreover, functional profiling will be conducted.
Methods: Our aim is to enroll 32 OCD patients and 32 matched controls. Shotgun metagenomic sequencing will be used. Sequenced data will be processed followed by non-parametric statistical testing.
Significance: gut microbiome in patients with OCD beofre and after ERP treatment has never been done before. The microbial composition may impact on OCD symptoms, severity, and chronicity and could inform future therapeutic possibilities.
详细描述
Background:
Obsessive-compulsive disorder (OCD) is a highly debilitating disorder with a lifetime prevalence of approximately 2% is equally distributed among men and women. OCD generally starts at an early age and usually develops a chronic course if left untreated. Many patients with OCD receive treatment after years of delay due to both patient and health care factors; therefore, OCD affects educational achievement, ability to work and interpersonal relationships. Moreover, it poses a considerable burden and distress to family caregivers [1], and accounts for one of the ten most disabling mental health conditions worldwide [2].
The role of the microbial community in health and disease has been a neglected subject in human research until recently, despite the fact that human microbes comprise about 1-3 % of our body mass [3]. Gut microbes play important roles in nutrient metabolism, production of vitamins, and prevention of pathogens from colonizing our intestine [4]. Recently, microbiota in the gut has gained increasing interest due the extensive connection between the gut and the brain [5]. The bidirectional communication through neural, hormonal, and immunological signaling involving the central, autonomic, and enteric nervous systems forms the microbiome-gut-brain axis [6]. In psychiatry, dysbioses have been reported in anorexia nervosa, major depression, autism, and other major psychiatric disorders [9, 10].
Association between OCD onset and infection has long been known. PANS/PANDAS are acute-onset forms of OCD associated with autoimmune reactions from pathogens such as streptococcus infection [11, 12]. The connection between bacterial pathogen and immunological response, which generates OCD symptoms, is further evidence for the importance of the microbiome-gut-brain axis in OCD. Lately, there have been numerous hypotheses regarding the importance of gut microbiome and OCD symptoms [13, 14].
Aims: Characterize composition and diversity of the gut microbiome in individuals with OCD compared with healthy controls.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-5 diagnosis of OCD. Age matched controls will be recruited who have no personal or family history of OCD.
排除标准
- •history of GI tract surgery (other than appendectomy or cholecystectomy); history of inflammatory bowel disease, irritable bowel syndrome, celiac disease, or any other diagnosis that could explain chronic or recurring bowel symptoms, antibiotic use in the past 3 months; pro-biotic use in the past 4 weeks; pregnancy. Intellectual disability, autism spectrum disorder and psychotic disorders.
结局指标
主要结局
Alpha diversity
时间窗: 2018-09-01
expressed as number of observed species and Chao-1 estimator
次要结局
- Beta diversity(2018-09-01)
- Taxonomic and functional differences between cases and controls(2018-09-01)
- Change in microtioba diversity before and after ERP treatment(2018-09-01)
研究者
Christian Rück
Head of Rucklab, affiliate professor
Karolinska Institutet