A 12-week Randomized Controlled Trial of Probiotic Treatment (Lactobacillus Helveticus R0052 and Bifidobacterium Longum R0175) vs Placebo in Adult Obsessive Compulsive Disorder
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Yale Brown Obsessive-Compulsive Scale [YBOCS]
研究概览
简要总结
This study will evaluate the effectiveness of 12-weeks of probiotic treatment in adults with primary Obsessive-Compulsive Disorder and whether this treatment will alter the microbiota composition in these patients.
详细描述
The study will be a prospective, randomized, double blind placebo-controlled trial. The study population will include males and females, ages 18-65, who fulfill criteria for primary DSM-5 OCD as determined by a structured interview. At screening, patients must have a YBOCS score ≥20 and a MADRS score ≤18.
If deemed eligible, patients will provide a stool sample for microbiome profiling and a blood sample for the inflammatory marker analysis. They will return for their first visit where clinician and self-rated symptom severity scales will be completed and patients will begin their randomly assigned treatment condition. Contents of two sachets (probiotic or placebo) will be consumed daily with or just after breakfast.The participants will attend 3 additional study visits, once every 4 weeks and one phone visit at week 6. During these visits, the same clinician and self-reported questionnaires will be completed. At week 6, patients will be contacted by phone to complete the YBOCS and will also provide a midpoint stool sample. At the final visit (week 12) patients will provide a third stool sample for microbiome profiling and a blood sample for inflammatory marker analysis.
Participants will be assessed using the Mini International Neuropsychiatric Interview (MINI) to determine whether criteria for a primary OCD diagnosis is met alongside any additional comorbid disorders.
Participants will complete a number of clinician and self-rated symptom severity scales as listed below:
- Yale Brown Obsessive-Compulsive Scale (YBOCS) - Clinician-rated
- Montgomery Asberg Depression Rating Scale (MADRS) - Clinician-rated
- Obsessive-Compulsive Inventory - Revised (OCI-R) - Self-rated
- Depression Anxiety Stress Scale (DASS-21) - Self-rated
- Dutch Dimensional Obsessive-Compulsive Scale (DDOCS) - Self-rated
- Sheehan Disability Scale (SDS) - Self- rated
- Quality of Life and Enjoyment Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), Self-rated
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with a principal diagnosis of OCD (DSM 5) according to the MINI with a Y-BOCS score of ≥20
- •The ability to comprehend and satisfactorily comply with protocol requirements
- •Written informed consent given prior to beginning of the study.
- •Current use of any psychotropic agent is permitted given that that individual has been on a stable dose for at least 8 weeks.
排除标准
- •Participants with current Major Depressive Disorder.
- •A MADRS score ≥
- •Patients with significant suicidal ideation (MADRS item 10 ≥ 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- •Individuals with current autoimmune disorders (rheumatoid arthiritis, systemic lupus erythematosus, multiple sclerosis, etc.), inflammatory bowel disease, diabetes.
- •Current use of herbal psychoactive treatments i.e. St. John's Wort, Kava Kava, Chamomile Extract, Valeria. Past use is permitted if treatment ended 3 months prior to entering the study and stool sampling.
- •Participants receiving current psychotherapy, including cognitive behavioural therapy for an anxiety or mood disorder. Past psychotherapy is permitted if treatment ended 3 months prior to entering the study and stool sampling.
- •Patients who currently fulfill criteria for a lifetime history of bipolar disorder, history of drug abuse, a history of schizophrenia or other psychotic disorders, delirium, dementia and amnesic and other cognitive disorders, or are in a current agitated state.
- •Patients meeting criteria for current substance use disorder.
- •Antibiotic or probiotic use within 8 weeks of entering the study and stool sampling.
- •Reports frequent consumption of foods rich in/enriched with probiotics (yogurt etc).
- •Individuals with immune-compromised conditions (i.e. AIDS, lymphoma) or those undergoing long-term corticosteroid treatment.
- •Individuals with a soy or lactose allergy.
- •Female participants must not be breastfeeding, pregnant or seeking to get pregnant during the course of this study.
- •History of allergic response to probiotics or any other related drugs.
- •Currently physically unwell including experiencing nausea, fever, vomiting, abdominal pain, bloody diarrhea.
- •Individuals with prosthetic heart valves, or a history of valvular heart disease.
结局指标
主要结局
Yale Brown Obsessive-Compulsive Scale [YBOCS]
时间窗: 12 weeks
Clinical Global Impression - Improvement ≤ 2 [CGI-I]
时间窗: 12 weeks
次要结局
- Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire(12 weeks)
- Montgomery-Asberg Depression Rating Scale (MADRS)(12 weeks)
- Obsessive-Compulsive Inventory - Revised(12 weeks)
- Depression Anxiety Stress Scale(12 weeks)
- Sheehan Disability Scale(12 weeks)
- Dutch Dimensional Obsessive-Compulsive Scale(12 weeks)