Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Biological Signatures, Probiotic Among Those With mTBI and PTSD
NCT02723344 · View on ClinicalTrials.gov ↗
Study Summary
Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability to and aggravation and perpetuation of adverse consequences among those with co-occurring mild TBI (mTBI) and post-traumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic to treat chronic symptoms associated with co-occurring mTBI and PTSD among Veterans. By looking at the impact of probiotic supplementation on biological signatures of increased inflammation, as reflected by the gut microbiota, gut permeability, and biomarkers of peripheral inflammation, this study may lead to the identification of a novel intervention for the treatment of symptoms associated with these frequently co-occurring conditions.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT of Lactobacillus reuteri (L. reuteri; DSM 17938)
- OTHER Sunflower and medium chain triglyceride oils
Study Locations (1)
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2016-08-01 |
| Est. Completion | 2019-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02723344
The ClinicalTrials.gov registry entry for NCT02723344 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions — of which of Lactobacillus reuteri (L. reuteri; DSM 17938) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02723344 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02723344 about?
NCT02723344 is a clinical study titled "Biological Signatures, Probiotic Among Those With mTBI and PTSD". Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability to and aggravation and perpetuation of adverse consequences among those with co-occurring mild TBI (mTBI) and post-traumatic stress disorder (PTSD). The proposed study begins the process of investigating th...
What is the current status of trial NCT02723344?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2016-08-01. Estimated completion is 2019-06-01.
What conditions does trial NCT02723344 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Mild Traumatic Brain Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02723344?
The interventions under investigation include: of Lactobacillus reuteri (L. reuteri; DSM 17938) (DIETARY_SUPPLEMENT), Sunflower and medium chain triglyceride oils (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02723344?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02723344 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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