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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Uzhhorod, 우크라이나, 88000
- Uzhhorod National University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 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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실험적: 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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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in PTSD symptom severing
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Nadiya Boyko, Dr of Biological Science Prof, Uzhhorod National University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UzhNU-PTSD-2026-01
- EC No3/1 29/03/2024 (기타 식별자: Bioethics Commission Uzhhorod National University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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