A Clinical Trial to Evaluate the Safety and Tolerability of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
Obsessive-compulsive disorder (OCD) is a psychiatric condition marked by recurrent intrusive thoughts (obsessions) and ritualistic behaviors aimed at reducing distress (compulsions). While there exist a number of medications to treat this illness, half of those who need them either do not respond or can not tolerate current medications because of side effects. Therefore, there is an urgent need to develop new ways to treat this illness. One of the areas being explored as a potential option is based on what is now known as a strong link between the bacteria that live in our gut and the brain. Research has shown that a fecal transplant of the gut bacteria from healthy donors is able to improve health outcomes for people with depression and the investigators now want to expand this into OCD, given a known link between this condition and bacterial infection. To do this the investigators will use both the standard methods of bacterial identification via stool analysis, which looks at large bowel changes, and compare it to the Small Intestine Microbiome Aspiration (SIMBA) system, a small capsule that when swallowed allows a fluid sample to be collected from the participants' small intestine. This work will help the investigators assess the benefits of fecal transplant in OCD, and more importantly, identify how transplant changes the system, utilizing a novel technology to move the field forward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who have a primary diagnosis of OCD
- •on a stable appropriate dose of (SSRI) treatment for at least 12 weeks prior to Baseline
- •insufficient response to current SSRI treatment indicated by persistence of symptoms.
排除标准
- •Participant meets Diagnostic criteria for substance use, eating disorder, schizophrenia, or schizoaffective disorder
- •Suicidality
- •regular intake of antibiotics, prebiotics, or probiotics
- •Clinically diagnosed with IBD, Crohn's disease, Ulcerative colitis, or Celiac disease
- •Immune suppression
- •intestinal obstruction
- •Oropharyngeal dysphagia or other swallowing disorder
- •< 2 bowel movements per week
- •Breastfeeding, pregnant or seeking to get pregnant during the course of this study
结局指标
主要结局
Adverse Events
时间窗: 0-13 weeks
Reported Adverse events
Toronto Side Effects Scale (TSES)
时间窗: 0-13 weeks
Changes in the Toronto Side Effects Scale (TSES). TSES a 32-item instrument used to evaluate the incidence, frequency, and severity of the central nervous system (CNS), gastrointestinal (GI), and sexual side effects.
次要结局
- Global function/overall improvement (The General Anxiety Disorder-7 scale (GAD-7))(0-13 weeks)
- Global function/overall improvement (Patient Health Questionnaire-9(PHQ9))(0-13 weeks)
- OCD symptoms (Y-BOCS)(0-13 weeks)
- Next generation fecal, Urine, Blood and saliva sequencing(0-13 weeks)
- OCD symptoms (TOCS)(0-13 weeks)
- Global function/overall improvement (Quick Inventory of Depressive Symptomatology-Self-Report (QIDS))(0-13 weeks)
- Global function/overall improvement (Positive and Negative Affect Schedule (PANAS))(0-13 weeks)
研究者
Valerie Taylor
MD, Phd, FRCPC, Professor, Department Head
University of Calgary
