Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Dietary effect on the fractional representation of faecalibacterium in the gut microbiome.
研究概览
简要总结
The objective of this study is to determine how specific dietary control alters the microbiome composition to effect clinical outcome measures in a longitudinal study of individuals with bipolar disorder. Our central hypothesis is that a low carbohydrate (CHO) / high polyunsaturated fat (PUFA) diet will increase the fractional representation of specific butyrate producing members of the Firmicutes phylum in the gut microbiome, which will attenuate host inflammation, improve sleep quality and reduce anxiety in bipolar patients. The rationale for the proposed research is to take the first step in a continuum of studies to develop personalized novel approaches to treat mood disorders, including the need to address gut dysbiosis, which often co-occurs with mental illness. The investigators will test our hypothesis and achieve the objective of this proposal with the following Specific Aims: 1) Determine the taxonomical change in the stool microbiome following a low CHO / high PUFA diet; and 2) Determine the changes in sleep quality, anxiety, and depression following a low CHO / high PUFA diet. These aims will be achieved using the unique resources at the University of Michigan, including the Nutrition Assessment Laboratory for dietary intervention, the Host-Microbiome Laboratory for microbial assays, and the ongoing Prechter Longitudinal Study of Bipolar Disorder. At the end of the proposed studies the investigators expect to set the stage for future studies to assess neurochemical mechanisms. These data will provide a greater understanding of the mechanism by which diet controls the specific microbes in the gut microbiome to affect mood disorders and gut dysbiosis and improve response to psychiatric treatment paradigms.
详细描述
RECRUITING AND INCENTIVIZING RESEARCH PARTICIPANTS
For the proposed study, the investigators will recruit research participants from the Prechter Longitudinal Study of Bipolar Disorder, housed at the University of Michigan under the direction of Dr. Melvin McInnis, mentor on this application. The Prechter study is in its 10th year with over 1200 participants, including psychiatric and healthy control individuals. the investigators have successfully recruited from this study in the past to perform an observational dietary study and single point microbiomic analysis described in the Previous Work section. The investigators will leverage the infrastructure of the study with 50% dedicated time for a research assistant to manage recruitment, scheduling, follow up and data entry duties. The investigators will also leverage 5% dedicated time for the study coordinator, Gloria Harrington, who oversees all administrative aspects of the Prechter Study, including assurance of regulatory compliance.
The investigators will recruit 20 males and 20 females from the Prechter cohort, aged 25-65 with a confirmed diagnosis of Bipolar I disorder from a diagnostic interview for genetic studies (DIGS), used as the baseline intake instrument for the Prechter study. Eligible subjects will be consented and scheduled for an intake interview and assigned a unique identification number for tracking with a secure laboratory information management system. Subjects will be offered a monetary incentive of $200, paid in installments after completion of study milestones activities.
DETERMINING HABITUAL DIETS
The investigators will determine the habitual baseline diets of all subjects using a 3 non consecutive days over 1 week with an automated online 24-hour diet recall (ASA24 from the National Cancer Institute). Subjects will meet with a certified nutritionist from the Nutrition Assessment Laboratory in the Nutrition and Obesity Research Center at the University of Michigan during the consent visit to explain how to use the recall appropriately. After 1 week, subjects will return for to the MCRU for baseline biological samples and dietary guidance as detailed below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current participation in Prechter Longitudinal Study of Bipolar disorder at the University of Michigan (HUM00000606)
- •Confirmed diagnosis of Bipolar I or no diagnosis (controls)
排除标准
- •Daily smoking habit
- •Excessive alcohol defined as more than 2 drinks per day on average.
- •An extremely poor diet determined by a nutritional interview as eating less than 1 planned meal per day.
- •Food allergies or sensitivities.
- •Anti-biotic use in the past 3 months.
研究组 & 干预措施
Dietary Intervention Group
Subject will be guided to eat a high polyunsaturated fatty acid diet.
干预措施: High polyunsaturated fatty acid diet. (Other)
结局指标
主要结局
Dietary effect on the fractional representation of faecalibacterium in the gut microbiome.
时间窗: Baseline and approximately 4 weeks from baseline
The primary outcome will be measured as an increase in fractional representation of faecalibacterium, as measured by 16S ribosomal DNA sequencing of stool samples at baseline and 4 weeks of dietary manipulation. Sequence data will be analyzed as described in the mothur SOP (see links section of the PRS).
次要结局
未报告次要终点
研究者
Melvin McInnis, MD
Professor
University of Michigan