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NCT04150380 · ClinicalTrials.gov registry record · Phase 2
Probiotic (LGG) for Veterans With PTSD
A Phase 2 study, sponsored by VA Eastern Colorado Health Care System.
- Completed
- Registry status
- Phase 2
- Development phase
- 383
- Enrollment target
NCT04150380: Completed Phase 2 study, sponsored by VA Eastern Colorado Health Care System.
NCT04150380 is a Phase 2 study that has completed, run by VA Eastern Colorado Health Care System. The registered enrollment target is 383 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04150380, a Phase 2 study, has completed, sponsored by VA Eastern Colorado Health Care System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 383 participants
- Enrollment target
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 posttraumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic, Lactobacillus rhamnosus GG (LGG; ATCC53103), to treat chronic symptoms associated with PTSD among Veterans. By looking at the impact of probiotic supplementation on biological signatures of increased inflammation, as reflected by biomarkers of inflammation, gut microbiota composition, intestinal permeability, stress response, decision making, and PTSD symptoms, this study may identify a novel intervention for the treatment of symptoms associated with this frequently occurring condition.
Primary Outcome
Blood biomarker of inflammation
Interventions
- OTHER Placebo
- BIOLOGICAL Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2020-08-24 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the finished NCT04150380 record still lists
NCT04150380 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04150380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04150380 about?
NCT04150380 is a clinical study titled "Probiotic (LGG) for Veterans With 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 posttraumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulator...
What is the current status of trial NCT04150380?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 383 participants. The study started on 2020-08-24. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT04150380?
The interventions under investigation include: Placebo (OTHER), Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04150380?
This trial is sponsored by VA Eastern Colorado Health Care System, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04150380's enrollment target sits among peer trials
383 111th of 2000 higher than 1,890 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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