Schizophrenia and the Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 16S rRNA gene amplicons from stool samples
研究概览
简要总结
In a sample of 20 inpatients with a DSM-IV-TR/DSM 5 diagnosis of schizophrenia or schizoaffective disorder, investigators propose to conduct a prospective, 2 week observational trial to collect gastrointestinal stool samples in order to characterize the microbiota in people with schizophrenia and examine its variability over time. Participants may elect to participate for an additional two weeks, during which they will receive the prebiotic, oligofructose-enriched inulin (FOS), in order to examine its effects on the relative preponderance of butyrate-producing bacteria in the gut microbiome. Investigators will use an inpatient sample in order to standardize meals, exercise and environmental mediators. This is considered a feasibility, pilot study in order to apply for future grant funding. Investigators will recruit patients from the Treatment Research Program inpatient unit, Maryland Psychiatric Research Center, University of Maryland School of Medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV-TR /DSM 5 diagnosis of schizophrenia or schizoaffective disorder;
- •Age 18-64 years;
- •currently hospitalized for at least 7 days
- •currently treated with an antipsychotic, with no dose changes in last 14 days
- •ability to participate in the informed consent process, as determined by a score of 10 or greater on the Evaluation to Sign Consent
排除标准
- •Gastrointestinal disorders, including, but not limited to Crohn's Disease, Irritable Bowel Syndrome, Celiac Disease,
- •Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
- •Mental retardation
- •Antibiotic or immune therapy within the last three months
- •Prebiotic or probiotic treatment within the last three months
- •Inability to understand English
- •Inability to cooperate with study procedures
- •Pregnant women
- •Prisoner status
- •For MRI ONLY Contraindication for MRI scanning (e.g. metal in body, pacemaker).
结局指标
主要结局
16S rRNA gene amplicons from stool samples
时间窗: 4 weeks
The 16S rRNA gene amplicon data will be used to examine the relative preponderance of butyrate-producing bacteria in the gut microbiota of people with schizophrenia.
次要结局
未报告次要终点
研究者
Robert Buchanan
Director, Maryland Psychiatric Research Cente
University of Maryland, Baltimore