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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Uzhhorod, Oekraïne, 88000
- Uzhhorod National University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: 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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Experimenteel: 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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Actieve vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in PTSD symptom severing
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nadiya Boyko, Dr of Biological Science Prof, Uzhhorod National University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UzhNU-PTSD-2026-01
- EC No3/1 29/03/2024 (Andere identificatie: Bioethics Commission Uzhhorod National University)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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