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NCT02723344 · ClinicalTrials.gov registry record · Phase 1
Biological Signatures, Probiotic Among Those With mTBI and PTSD
A Phase 1 study of Post Traumatic Stress Disorder and Mild Traumatic Brain Injury, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT02723344: Completed Phase 1 study of Post Traumatic Stress Disorder and Mild Traumatic Brain Injury, sponsored by VA Office of Research and Development.
NCT02723344 is a Phase 1 study of Post Traumatic Stress Disorder and Mild Traumatic Brain Injury that has completed, run by VA Office of Research and Development. The registered enrollment target is 75 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02723344, a Phase 1 study of Post Traumatic Stress Disorder and Mild Traumatic Brain Injury, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Inflammation - Biological Signature (Blood)
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 |
What the finished NCT02723344 record still lists
NCT02723344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (89% lower).
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.
NCT02723344 reports a single indexed study location in Colorado.
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.
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).
Who is sponsoring clinical trial NCT02723344?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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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participants (enrollment target), bucketed by value
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