PTSD - Post Traumatic Stress DisorderRAPID RECOVERYNCT07623967
Rapid Recovery: Gut Microbiome Correction for PTSD
A study testing Investigational Probiotic Preparation in people with PTSD - Post Traumatic Stress Disorder, run by Uzhhorod National University at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Investigational Probiotic Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Jul 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- Chronic cerebral ischemia
- Back pain
- Blast injuries
- Arterial hypertension
- Degenerative-dystrophic spinal diseases
- Spinal cord injury
Who cannot join
- Pregnancy or history of pregnancy within the last 12 months
- Multiple organ failure
- Apallic state
- Incurable patients
- Prolonged coma
- Severe traumatic brain injury
Show all 9Show fewer
- Psychiatric disorders (as a separate diagnosis)
- Alcohol abuse
- Current antibiotic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Investigational Probiotic Preparation
- Keywords
- PTSD, Microbiome, Gut-Brain Axis, Cohort Study, Mental Health, Personalized Medicine
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Probiotic PreparationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Investigational Probiotic Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jul 2024
- Primary completion1 Jul 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uzhhorod National University
- Sponsor type
- University, hospital or other
- Collaborators
- Danylo Halytsky Lviv National Medical University, LLC EDIENS, Uzhhorod City Multidisciplinary Hospital
- Responsible party
- Sponsor
- Investigators
- Nadiya Boyko, Dr of Biological Science Prof, Principal investigator, Uzhhorod National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623967
- Sponsor's protocol ID
- UzhNU-PTSD-2026-01
- Other IDs
- EC No3/1 29/03/2024
- Acronym
- RAPID RECOVERY
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision about IPD sharing has not been made yet. Any future sharing will comply with Ukrainian data protection laws and ethical committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Clinical Trials "Microbiome as a Factor Influencing Mental Health, Individualized Correction of Mental Health in Persons With Post-Traumatic Stress Disorder"
- ClinicalTrials.gov ID
- NCT07623967
- Acronym / sponsor ID
- RAPID RECOVERY / UzhNU-PTSD-2026-01
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- PTSD, Microbiome, Gut-Brain Axis, Cohort Study, Mental Health, Personalized Medicine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Uzhhorod National UniversityUniversity, hospital or other
- Collaborators
- Danylo Halytsky Lviv National Medical University, LLC EDIENS, Uzhhorod City Multidisciplinary Hospital
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Investigational Probiotic PreparationMilitary personnel diagnosed with PTSD receiving a personalized investigational probiotic preparation administered as lyophilized powder for 14 days. |
| Military Personnel without PTSD | Active comparator | Drug: Investigational Probiotic PreparationMilitary 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. |
| Internally Displaced Persons (IDP) | Experimental | Drug: Investigational Probiotic PreparationInternally displaced persons experiencing war-related psychological stress receiving a personalized investigational probiotic preparation administered as lyophilized powder for 14 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age 18 to 60 years
Key exclusion criteria (9 listed)
- Pregnancy or history of pregnancy within the last 12 months
- Multiple organ failure
- Apallic state
- Incurable patients
- Prolonged coma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Probiotic PreparationA 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. | Drug | Internally Displaced Persons (IDP), Military Personnel with PTSD, Military Personnel without PTSD |
Primary outcome
Change in PTSD symptom severing
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Undecided. The decision about IPD sharing has not been made yet. Any future sharing will comply with Ukrainian data protection laws and ethical committee approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadiya Boyko, Dr of Biological Science Prof principal investigator
Uzhhorod National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Probiotic Preparation in people with PTSD - Post Traumatic Stress Disorder, run by Uzhhorod National University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptom severing (time frame: Baseline to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.