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Rapid Recovery: Gut Microbiome Correction for PTSD

NCT07623967 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-06-03

No results posted yet for this study

Summary

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:

1. identify associations between gut microbiome composition, cognitive impairment, anxiety-depressive disorders, and PTSD;
2. 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.

Conditions

  • PTSD - Post Traumatic Stress Disorder

Interventions

DRUG

Investigational Probiotic Preparation

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.

Sponsors & Collaborators

  • Danylo Halytsky Lviv National Medical University

    collaborator OTHER

  • LLC EDIENS

    collaborator UNKNOWN

  • Uzhhorod City Multidisciplinary Hospital

    collaborator UNKNOWN

  • Uzhhorod National University

    lead OTHER

Principal Investigators

  • Nadiya Boyko, Dr of Biological Science Prof · Uzhhorod National University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-07-01
Completion
2027-12-31

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623967 on ClinicalTrials.gov