A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Time to First Rehospitalization
研究概览
简要总结
The purpose of this study is to determine if taking a probiotic supplement versus a placebo will lower rates of relapse and improve the clinical course among participants who have been hospitalized for mania. Relapse and clinical course are measured by time to re-hospitalizations, new mood episodes, and changes in mood-related symptoms.
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
- Triple (Participant, 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
- •Age 18-65
- •Capacity for written informed consent
- •Currently admitted to a Sheppard Pratt inpatient or day hospital for symptoms of mania
- •Primary Axis I diagnosis (DSM-IV) at time of admission of Bipolar I Disorder (single manic episode, most recent episode manic, or most recent episode mixed) OR Schizoaffective Disorder, Bipolar type (manic or mixed state)
- •Proficient in the English language
- •Available to come to Sheppard Pratt Towson for follow-up visits
- •Participated previously in one of our screening studies
排除标准
- •Diagnosis of mental retardation
- •Symptoms of mania secondary to a general medical condition
- •Any clinically significant or unstable medical disorder as determined by the investigators including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition
- •History of IV drug use
- •Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last 3 months, or has a positive drug toxicity screen
- •Participated in any investigational drug trial in the past 30 days
- •Pregnant or planning to become pregnant during the study period
- •Receipt of antibiotic medication within the previous 24 hours (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics)
- •Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care). Of note, we are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as we intend to look at these levels as a predictor of response.
研究组 & 干预措施
Probiotic Supplement
The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.
干预措施: Probiotic Supplement (Dietary Supplement)
Inert Compound
The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.
干预措施: Inert Compound (Dietary Supplement)
结局指标
主要结局
Time to First Rehospitalization
时间窗: Weeks 0 - 24 of study participation
The primary outcome was the time to first psychiatric inpatient rehospitalization.
次要结局
- Number of Participants Rehospitalized(Weeks 0 - 24 of study participation)
- Total Number of Rehospitalizations(Weeks 0 - 24 of study participation)
- Mean Days Rehospitalized(Weeks 0 - 24 of study participation)
研究者
Faith Dickerson
Head, Stanley Research Program
Sheppard Pratt Health System