Rapid Recovery: Gut Microbiome Correction for PTSD (RAPID RECOVERY)
Cohort Clinical Trials "Microbiome as a Factor Influencing Mental Health, Individualized Correction of Mental Health in Persons With Post-Traumatic Stress Disorder"
This cohort clinical trial (RAPID RECOVERY) investigates the role of gut microbiome in mental health and the effectiveness of personalized microbiome correction in individuals with post-traumatic stress disorder (PTSD). The study aims to:
- identify associations between gut microbiome composition, cognitive impairment, anxiety-depressive disorders, and PTSD;
- evaluate the impact of targeted microbiome correction using next-generation biotics (pharmabiotics) on recovery speed and neurological outcomes; 3 develop predictive models for PTSD risk using Data Science and Machine Learning approaches. Participants receive individually selected pharmabiotics based on their microbiome, immunological, and clinical profiles.
Outcomes include changes in PTSD symptom severity (PCL-5), anxiety and depression levels (HADS), cognitive function (MoCA), immunological parameters (lymphocyte subpopulations, cytokines, immunoglobulins), and gut microbiome composition (NGS). The study is conducted at Uzhhorod National University in collaboration with Uzhhorod City Multidisciplinary Hospital and Danylo Halytskyi Lviv National Medical University.
研究概览
详细说明
This is a prospective interventional cohort clinical trial (RAPID RECOVERY) conducted at Uzhhorod National University, Uzhhorod City Multidisciplinary Hospital, and Danylo Halytskyi Lviv National Medical University. The study enrolls approximately 140 participants aged 18-60 years with cognitive impairment, anxiety-depressive disorders, or PTSD in the context of neurological conditions (traumatic brain injury, neuropathic pain, vertebrobasilar insufficiency, chronic cerebral ischemia, spinal injury, mine-explosion trauma, hypertension, degenerative spinal diseases).
Intervention: Participants receive individually selected pharmabiotics (next-generation biotics) provided by Ediens LLC. The selection is based on baseline gut microbiome profiling (NGS), immunological phenotyping (CD3, CD4, CD8, CD56/16, CD19, activation markers CD4/25/127, apoptosis receptors PD1R/PD1L on CD8, FASR/FASL on CD56, regulatory molecules CD38, TIM3), serum cytokines (IL-1β, TNF-α, IFN-γ, IL-4, IL-10), immunoglobulins (IgA, IgM, IgG, IgE), and routine blood biochemistry (glucose, bilirubin, ALT, AST, creatinine, urea).
Procedures: Baseline assessment includes medical history, physical examination, cognitive function (MoCA), anxiety and depression (HADS), PTSD symptom severity (PCL-5 for military and civilian versions). Biological samples (blood, stool, saliva) are collected at baseline and after the pharmabiotic course. Stool is analyzed by next-generation sequencing (NGS) of 16S rRNA or metagenomics. Saliva is tested for secretory IgA.
Follow-up: After completing the pharmabiotic course, all clinical, biochemical, immunological, and microbiome assessments are repeated. Changes in cognitive, anxiety-depressive, and PTSD symptoms are evaluated using the same scales. Adverse events are documented and reported.
Data analysis: Statistical analysis includes descriptive and inferential statistics. Machine learning and data science methods will be applied to develop predictive models for PTSD risk and recovery trajectories, integrating microbiome, immunological, and clinical data.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Uzhhorod、乌克兰、88000
- Uzhhorod National University
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
Age 18 to 60 years
- Male or female sex
- Presence of cognitive impairment, anxiety/depressive disorders, or post-traumatic stress disorder (PTSD) on the background of one or more of the following neurological conditions:
- Mild to moderate traumatic brain injury (TBI)
- Neuropathic pain
- Vertebrobasilar syndrome
- Chronic cerebral ischemia
- Back pain
- Blast injuries
- Arterial hypertension
- Degenerative-dystrophic spinal diseases
- Spinal cord injury
Exclusion Criteria:
Pregnancy or history of pregnancy within the last 12 months
- Multiple organ failure
- Apallic state
- Incurable patients
- Prolonged coma
- Severe traumatic brain injury
- Psychiatric disorders (as a separate diagnosis)
- Alcohol abuse
- Current antibiotic therapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Health Control
Healthy volunteers with no psychiatric diagnosis and no probiotic intervention.
Serve as a reference group for microbiome and psychological outcome comparisons.
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实验性的：Military Personnel with PTSD
Military personnel diagnosed with PTSD receiving a personalized investigational probiotic preparation administered as lyophilized powder for 14 days.
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A personalized lyophilized probiotic powder containing bacterial strains selected individually for each participant based on two principles: (1) antagonism toward conditionally pathogenic microorganisms identified in the participant's microbiome, and (2) synergy with resident commensal microbiota.
Administered orally for 14 consecutive days.
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有源比较器：Military Personnel without PTSD
Military personnel without PTSD diagnosis receiving a personalized investigational probiotic preparation administered as lyophilized powder for 14 days.
Serves as a comparator to assess PTSD-specific microbiome-mediated effects.
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A personalized lyophilized probiotic powder containing bacterial strains selected individually for each participant based on two principles: (1) antagonism toward conditionally pathogenic microorganisms identified in the participant's microbiome, and (2) synergy with resident commensal microbiota.
Administered orally for 14 consecutive days.
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实验性的：Internally Displaced Persons (IDP)
Internally displaced persons experiencing war-related psychological stress receiving a personalized investigational probiotic preparation administered as lyophilized powder for 14 days.
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A personalized lyophilized probiotic powder containing bacterial strains selected individually for each participant based on two principles: (1) antagonism toward conditionally pathogenic microorganisms identified in the participant's microbiome, and (2) synergy with resident commensal microbiota.
Administered orally for 14 consecutive days.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in PTSD symptom severing
大体时间：Baseline to 14 days
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Change from baseline in the PTSD checklist for DSM-5 (PCL-5) score at 14 days.
The PLS-5 consists of 17 items, each rated 0-4, total score range 0-85.
Higher scores indicate more severe PTSD symptoms
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Baseline to 14 days
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合作者和调查者
合作者
调查人员
- 首席研究员：Nadiya Boyko, Dr of Biological Science Prof、Uzhhorod National University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- UzhNU-PTSD-2026-01
- EC No3/1 29/03/2024 (其他标识符：Bioethics Commission Uzhhorod National University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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