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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Uzhhorod, Ukraine, 88000
- Uzhhorod National University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Health Control
Healthy volunteers with no psychiatric diagnosis and no probiotic intervention.
Serve as a reference group for microbiome and psychological outcome comparisons.
|
|
|
Eksperimentel: Military Personnel with PTSD
Military personnel diagnosed with PTSD receiving a personalized investigational probiotic preparation administered as lyophilized powder for 14 days.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
|
Eksperimentel: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in PTSD symptom severing
Tidsramme: Baseline to 14 days
|
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
|
Baseline to 14 days
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nadiya Boyko, Dr of Biological Science Prof, Uzhhorod National University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UzhNU-PTSD-2026-01
- EC No3/1 29/03/2024 (Anden identifikator: Bioethics Commission Uzhhorod National University)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med PTSD - Posttraumatisk stresslidelse
-
Acacia ClinicsElectroCore INC; Vagus Nerve SocietyRekrutteringPTSD | Post traumatisk stress syndrom | Posttraumatisk stresslidelse | Posttraumatisk stresslidelse (PTSD) | Posttraumatisk stresslidelse PTSD | PTSD - Posttraumatisk stresslidelse | Posttraumatisk stresslidelse, PTSDForenede Stater
-
University of LuxembourgQuresta, Inc.; National Psychological Association of Ukraine; Veteran Mental...RekrutteringPost traumatisk stress syndrom | Posttraumatisk stresslidelse PTSD | Posttraumatisk stresslidelse, PTSDUkraine
-
Tulane University School of MedicineThe Arnold P. Gold FoundationAfsluttet
-
Oui Therapeutics, Inc.National Institute of Mental Health (NIMH); Florida State UniversityRekrutteringPTSD | Post traumatisk stress syndromForenede Stater
-
The University of Texas Health Science Center at...United States Department of DefenseRekrutteringPTSD | Post traumatisk stress syndromForenede Stater
-
Unity Health TorontoUniversity of Ottawa; Toronto Metropolitan UniversityIkke rekrutterer endnuPTSD | Post traumatisk stress syndrom | Kronisk PTSDCanada
-
University of Texas Southwestern Medical CenterTexas Child Mental Healthcare Consortium (TCMHCC)Aktiv, ikke rekrutterendePosttraumatisk stresslidelse i ungdomsårene | PTSD - Posttraumatisk stresslidelse | PTSD og traume-relaterede symptomer | Graviditet og PTSDForenede Stater
-
Jens Rikardt AndersenOslo University HospitalAfsluttetPTSD | Post traumatisk stress syndromNorge
-
VA Office of Research and DevelopmentRekrutteringPTSD | Stresslidelser, traumatiske | Traumer og stressor-relaterede lidelser | Post traumatisk stress syndrom | Post-traumatisk stresslidelseForenede Stater
-
Asad Ullah JanCMH NowsheraAfsluttet
Kliniske forsøg med Investigational Probiotic Preparation
-
Victoria CollottaAktiv, ikke rekrutterende
-
Victoria CollottaAktiv, ikke rekrutterende
-
Sinai UniversityIkke rekrutterer endnu
-
Aswan University HospitalAfsluttetEnterocolitis | Hirschsprung sygdom | Hirschsprungs sygdom associeret enterocolitisEgypten
-
Connecticut Children's Medical CenterTrukket tilbage
-
Cutera Inc.AfsluttetPigmenteret hudlæsion af mistænkt godartet karakterForenede Stater
-
CochlearAktiv, ikke rekrutterende
-
Société des Produits Nestlé (SPN)University of NottinghamAfsluttetSund og raskDet Forenede Kongerige
-
Medtronic Cardiac Rhythm and Heart FailureAfsluttetHjertefejlForenede Stater