The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Quantify absolute abundance of gut microbiome using metagenomic analysis at baseline
研究概览
简要总结
The aim of this study is to characterize the microbiome of patients undergoing post-acute residential neurorehabilitation compared to community controls and to determine if a dietary fiber, Inulin, can create a shift in the microbiome leading to changes in fatigue and cognition.
详细描述
The investigative research team previously described Brain Injury Associated Fatigue and Altered Cognition (BIAFAC) as a treatable syndrome that occurs in a subset of patients following traumatic brain injury (TBI). In addition to fatigue and brain fog, BIAFAC patients have altered growth hormone (GH) secretion, reduced serum amino acid levels, and an altered (dysbiotic) gut microbiome. GH treatment dramatically improves patient symptoms but is not curative; symptoms return when GH treatment ends and the associated gut dysbiosis is not corrected. In preliminary work with mouse models created using human fecal transplants from clinical BIAFAC subjects, transplanting the dysbiotic gut bacteria from BIAFAC patients alone caused fatigue, altered cognition, and dysregulated GH secretion without any trauma or head injury. These mouse models indicate that gut dysbiosis has a causative role in the development of BIAFAC by triggering both altered GH secretion and neurologic symptoms. In this clinical trial a dietary fiber, Inulin, will be administered to patients undergoing neurorehabilitation after brain injury to create a shift in their microbiome.
Specific Aims
Aim 1. Identify differences in blood and fecal microbiome biomarkers of neurorehabilitation patients.
Specific Aim 1a. Identify differences in blood and fecal microbiome biomarkers between patients entering an inpatient post-acute neurorehabilitation program and community controls.
Specific Aim 1b. Identify correlations between biomarkers (blood and fecal microbiome), demographics (e.g. age, sex), and clinical factors (e.g. medical history) of post-acute neurorehabilitation patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Brain Injury Patients
- •Ages 18 and above
- •Admitted to Moody Neurorehabilitation Institute for care
- •Less than 6 months post-injury
- •English speaking
- •Must be able to eat and drink by mouth
- •Willing and able to comply with study procedures
- •Willing and able to provide consent (with LAR if needed)
- •Significant heart, liver, kidney, blood or respiratory disease
- •HIV, Hepatitis B or Hepatitis C
- •Pregnancy or becoming pregnant during the study
- •History of inflammatory bowel disease
- •History of celiac disease
- •Active diverticular disease
- •Known allergy to study agent
- •Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation
- •Community Control Subjects
- •Ages 18 and above
- •Have a family member who is admitted to Moody Neurorehabilitation Institute for care OR is working at Moody Neurorehabilitation Institute
- •English speaking
- •Willing and able to comply with study procedures
- •Willing and able to provide consent
- •FACs score ≤ 50
- •Trauma to head in last 6 months
- •Stroke in last 6 months
- •Significant heart, liver, kidney, blood or respiratory disease
- •HIV, Hepatitis B or Hepatitis C
- •Pregnancy or becoming pregnant during the study
- •History of inflammatory bowel disease
- •History of celiac disease
- •Active diverticular disease
- •Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation
排除标准
- 未提供
研究组 & 干预措施
Community Controls
Community Control subjects will not receive intervention.
Brain Injury Patients - no intervention
Brain injury patients receiving residential standard of care post-acute neurorehabilitation.
Brain Injury Patients - inulin intervention
Brain injury patients receiving residential standard of care post-acute neurorehabilitation plus 42 days of daily oral inulin supplementation (4g 2x daily).
干预措施: Inulin (Dietary Supplement)
结局指标
主要结局
Quantify absolute abundance of gut microbiome using metagenomic analysis at baseline
时间窗: baseline
Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.
Quantify absolute abundance of gut microbiome using metagenomic analysis after 42 days of inulin supplementation
时间窗: 42 days inulin treatment
Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.
Quantify absolute abundance of gut microbiome using metagenomic analysis at 3 months of discontinuation of inulin
时间窗: 3 months of discontinuation of inulin
Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.
Quantify absolute abundance of gut microbiome using metagenomic analysis at 6 months of discontinuation of inulin
时间窗: 6 months of discontinuation of inulin
Metagenomic analysis using a custom PCR array will be performed on stool samples to identify associated changes in microbiome absolute abundance at the genus and species level.
Fold change in relative abundance of gut microbiome using metatranscriptomic analysis from baseline to 42 days of inulin treatment
时间窗: From baseline to 42 days of inulin treatment
Metatranscriptomic analysis using a RNA seq will be performed on stool samples to identify associated fold changes in which genes are turned on and off.
Fold change in relative abundance of gut microbiome using metatranscriptomic analysis from baseline to 3 months after discontinuation of inulin treatment
时间窗: From baseline to 3 months after discontinuation of inulin treatment
Metatranscriptomic analysis using a RNA seq will be performed on stool samples to identify associated fold changes in which genes are turned on and off.
Fold change in relative abundance of gut microbiome using metatranscriptomic analysis from baseline to 6 months after discontinuation of inulin treatment
时间窗: From baseline to 6 months after discontinuation of inulin treatment
Metatranscriptomic analysis using a RNA seq will be performed on stool samples to identify associated fold changes in which genes are turned on and off.
次要结局
- Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline(baseline)
- Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale after 42 days of inulin treatment(42 days of inulin treatment)
- Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 3 months after discontinuation of inulin(3 months discontinuation of inulin)
- Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months discontinuation of inulin(6 months discontinuation of inulin)