Rapid Recovery: Gut Microbiome Correction for PTSD

NCT07623967 | Active Not Recruiting DMC

• 2 other identifiers: UzhNU-PTSD-2026-01EC No3/1 29/03/2024
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

PTSD; Microbiome; Gut-Brain Axis; Cohort Study; Mental Health; Personalized Medicine

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptom severing

  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

Study Arms (4)

Health Control

NO INTERVENTION

Healthy volunteers with no psychiatric diagnosis and no probiotic intervention. Serve as a reference group for microbiome and psychological outcome comparisons.

Military Personnel with PTSD

EXPERIMENTAL

Military personnel diagnosed with PTSD receiving a personalized investigational probiotic preparation administered as lyophilized powder for 14 days.

Drug: Investigational Probiotic Preparation

Military Personnel without PTSD

ACTIVE COMPARATOR

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.

Drug: Investigational Probiotic Preparation

Internally Displaced Persons (IDP)

EXPERIMENTAL

Internally displaced persons experiencing war-related psychological stress receiving a personalized investigational probiotic preparation administered as lyophilized powder for 14 days.

Drug: Investigational Probiotic Preparation

Interventions

Investigational Probiotic Preparation DRUG

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.

Internally Displaced Persons (IDP); Military Personnel with PTSD; Military Personnel without PTSD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uzhhorod National University: lead
• Danylo Halytskyi Lviv National Medical University: collaborator
• LLC EDIENS: collaborator
• Uzhhorod City Multidisciplinary Hospital: collaborator

Study Sites (1)

Uzhhorod National University

Uzhhorod, 88000, Ukraine

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Nadiya Boyko, Dr of Biological Science Prof

  Uzhhorod National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel-group, controlled clinical trial. Participants receive individually selected pharmacobiotics based on microbiome analysis (16S NGS and/or culture) compared to a control group. The intervention aims to correct gut microbiota to improve cognitive functions, anxiety, depression, and PTSD symptoms.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

UA (1)