Traumatic Brain Injury and the Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Characterization of fecal microbiome using molecular methods at month 3
研究概览
简要总结
The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut.
详细描述
The investigators will study subjects (aged 18-70 years) with a history of moderate/severe traumatic brain injury (n=10) and healthy controls (aged 18-70 years) (n=10). All subjects will undergo a 3-month intervention of oral inulin treatment. The traumatic brain injury subjects will be administered oral inulin twice daily for 3 months. Testing including cognitive function assessment (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and questionnaires of fatigue, mood and quality of life and sleep will occur at month 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. In addition, fecal samples for analysis of the GI microbiome will be collected at month -1, month 0, month 1, month 2, month 3, and month 6 along with an assessment of gastrointestinal health. Traumatic brain injury subjects will be selected from residents at a long term residential rehabilitation center. Healthy control subjects will be administered oral inulin twice daily with meals for 3 months. Quality of life will be assessed by questionnaires at months 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. Fecal samples will be collected at month -1, month 0, month 3 and month 6 for analysis of the GI microbiome along with an assessment of gastrointestinal health. A member of the study team will check monthly for adverse events and overall well-being and ensure compliance and ongoing consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Traumatic Brain Injury
- •Head trauma greater than two years prior manifesting in one or more of the following:
- •Loss of consciousness
- •Post-traumatic amnesia
- •Focal neurologic deficits
- •Persistent symptoms of increased arousal (e.g., difficulty falling or staying asleep, anger and hypervigilance)
- •Impairment in cognitive, social, occupational, or other important areas of functioning (e.g., problems with work and relationships)
排除标准
- •Traumatic Brain Injury
- •Unwilling to give consent. Patients with rights managed by Legal Authorized Representative must consent to participate in addition to consent from their legal agent
- •< 2 years post-injury
- •Known allergy to study agent.
- •Other medical condition or medication administration deemed exclusionary by the study investigators.
- •Inclusion Criteria:
- •Healthy Control
- •Ages 18 to 70 years
- •Works at Centre for Neuro Skills
- •Participant is willing and able to give informed consent for participation in the study.
- •Exclusion Criteria
- •Healthy Control
- •Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
- •Known allergy to study agent.
- •Other medical condition or medication administration deemed exclusionary by the study investigators.
结局指标
主要结局
Characterization of fecal microbiome using molecular methods at month 3
时间窗: month 3
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Characterization of fecal microbiome using molecular methods at baseline
时间窗: Baseline
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Characterization of fecal microbiome using molecular methods at month 1
时间窗: month 1
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Characterization of fecal microbiome using molecular methods at month 2
时间窗: month 2
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Characterization of fecal microbiome using molecular methods at month 6
时间窗: month 6
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
次要结局
- Asparagine at baseline(month 3)
- Norvaline at month 3(month 3)
- Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 3(month 3)
- Depression measured by the Beck Depression Inventory-II at month 6(month 6)
- Sleep Quality as measured by Pittsburgh Sleep Quality Index at baseline(Baseline (month 0))
- Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 3(month 3)
- Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 6(month 6)
- Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline(Baseline (month 0))
- Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at baseline(Baseline)
- 2-Aminobutyric Acid at baseline(Baseline (month 0))
- Alanine at baseline(Baseline (month 0))
- Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 2(month 2)
- Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 3(month 3)
- Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3(month 3)
- Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3(month 3)
- Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6(month 6)
- Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at baseline(Baseline (month 0))
- Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 6(month 6)
- Depression measured by the Beck Depression Inventory-II at baseline(Baseline (month 0))
- Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline(Baseline (month 0))
- Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 1(month 1)
- Depression measured by the Beck Depression Inventory-II at month 3(month 3)
- Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 6(month 6)
- Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6(month 6)
- Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6(month 6)
- 3 methyl Histidine at baseline(Baseline (month 0))
- Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline(Baseline (month 0))
- Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3(month 3)
- Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline(Baseline (month 0))
- Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at month 6(month 6)
- 2-Aminobutyric Acid at month 3(month 3)
- Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at month 3(month 3)
- 1 methyl Histidine at baseline(Baseline (month 0))
- 1 methyl Histidine at month 3(month 3)
- 3 methyl Histidine at month 3(month 3)
- L-alpha-Aminoadipic acid at baseline(Baseline (month 0))
- L-alpha-Aminoadipic acid at month 3(month 3)
- Arginine at month 3(month 3)
- D, L-beta-Aminoisobutyric acid(month 3)
- Citrulline at baseline(Baseline (month 0))
- Ethanolamine at baseline(Baseline (month 0))
- Aspartate at month 3(month 3)
- beta-Alanine at month 3(month 3)
- L-Carnosine(month 3)
- Glutamate at month 3(month 3)
- Glycine at month 3(month 3)
- Hydroxylysine at month 3(month 3)
- Alanine at month 3(month 3)
- Arginine at baseline(Baseline (month 0))
- Aspartate at baseline(Baseline (month 0))
- Cystathionine(month 3)
- Cysteine at baseline(Baseline (month 0))
- Cysteine at month 3(month 3)
- beta-Alanine at baseline(Baseline (month 0))
- Citrulline at month 3(month 3)
- Glutamine at baseline(Baseline (month 0))
- Glutamate at baseline(Baseline (month 0))
- Hydroxyproline at baseline(Baseline (month 0))
- Hydroxyproline at month 3(month 3)
- Norleucine at baseline(Baseline (month 0))
- Ethanolamine at month 3(month 3)
- Gamma aminobutyric acid at baseline(Baseline (month 0))
- Glutamine at month 3(month 3)
- Homocysteine at month 3(month 3)
- Hydroxylysine at baseline(Baseline (month 0))
- Lysine at month 3(month 3)
- Methionine at month 3(month 3)
- Phenylalanine at baseline(Baseline (month 0))
- Sarcosine at month 3(month 3)
- Threonine at month 3(month 3)
- Tyrosine at baseline(Baseline (month 0))
- Tyrosine at month 3(month 3)
- Gamma aminobutyric acid at month 3(month 3)
- Glycine at baseline(Baseline (month 0))
- Homocysteine at baseline(Baseline (month 0))
- Histidine at month 3(month 3)
- Isoleucine at baseline(Baseline (month 0))
- Ornithine at baseline(Baseline (month 0))
- Phenylalanine at month 3(month 3)
- Proline at month 3(month 3)
- Taurine at month 3(month 3)
- Tryptophan at baseline(Baseline (month 0))
- Histidine at baseline(Baseline (month 0))
- Isoleucine at month 3(month 3)
- Leucine at baseline(Baseline (month 0))
- Leucine at month 3(month 3)
- Methionine at baseline(Baseline (month 0))
- phospho-ethanolamine at baseline(Baseline (month 0))
- phospho-serine at month 3(month 3)
- Threonine at baseline(Baseline (month 0))
- Lysine at baseline(Baseline (month 0))
- Norleucine at month 3(month 3)
- Norvaline at baseline(Baseline (month 0))
- phospho-ethanolamine at month 3(month 3)
- Proline at baseline(Baseline (month 0))
- Sarcosine at baseline(Baseline (month 0))
- Serine at baseline(Baseline (month 0))
- Taurine at baseline(Baseline (month 0))
- Tryptophan at month 3(month 3)
- Ornithine at month 3(month 3)
- phospho-serine at baseline(Baseline (month 0))
- Serine at month 3(month 3)
- Valine at baseline(Baseline (month 0))
- Valine at month 3(month 3)