Prebiotic Treatment in People With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cognition
研究概览
简要总结
The proposed project is based on the observation that schizophrenia is characterized by a chronic pro-inflammatory state, which contributes to the severity of a number of the clinical manifestations of the illness, including cognitive impairments, the treatment of which represents a critically important unmet therapeutic need.
详细描述
The investigators hypothesize that the level of inflammation in people with schizophrenia can be reduced through the use of the prebiotic: Prebiotin®, an oligofructose-enriched inulin (OEI), to stimulate the activity of butyrate-producing bacteria and increase the production of butyrate, which has multiple anti-inflammatory properties. The investigators will confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance (primary specific aim), symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.
In a sample of participants with a DSM-5 diagnosis of schizophrenia or schizoaffective disorder, the investigators will conduct a 12-week, double-blind, placebo-controlled, randomized clinical trial to confirm the effect of prebiotic administration on the biological signature and examine whether increased serum butyrate levels are associated with changes in cognitive performance, symptoms, and metabolic measures; and the extent to which these associations are mediated by the anti-inflammatory properties of butyrate, including the ability of butyrate to decrease gut permeability and inhibit the production of pro-inflammatory cytokines, and/or changes in gut microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 diagnosis of schizophrenia or schizoaffective disorder;
- •Age 18-60 years;
- •Considered clinically stable by the treating psychiatrist;
- •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, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
- •Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, Loss of consciousness (LOC) for more than 30 minutes
- •Intellectual disability
- •Acute antibiotic use
- •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 or lactation secondary to pregnancy
- •Participants who meet DSM 5 criteria for alcohol or substance misuse (except caffeine and nicotine) within the last 3 months will be excluded. Participants who meet DSM 5 criteria for marijuana misuse - mild will be included in the study.
研究组 & 干预措施
Placebo
Participants randomized to active study medication will mix 4g of powder placebo with water, 3 times a day for 12 weeks.
干预措施: Placebo Prebiotic (Dietary Supplement)
Active Study Med
Participants randomized to active study medication will mix 4g of powder prebiotic with water, 3 times a day for 12 weeks.
干预措施: Prebiotic (Dietary Supplement)
结局指标
主要结局
Cognition
时间窗: 12 weeks
Number of participants with an increase in MCCB composite score at 12 weeks.
Change in serum butyrate levels
时间窗: 12 weeks
Number of participants with an increase in serum butyrate levels at 12 weeks.
Incidence of Side Effects
时间窗: 12 weeks
Number of participants with an increased incidence of side effects at 12 weeks.
次要结局
- Change in Affective Symptoms(12 weeks)
- Change in Positive Symptoms(12 weeks)
- Changes in Serum Measurements(12 weeks)
- Change in Negative Symptoms(12 weeks)
- Effects of Gut Composition(12 weeks)
研究者
Deanna Kelly
Director, Maryland Psychiatric Research Center (MPRC)
University of Maryland, Baltimore