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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 is a Phase 2 study that has completed, run by VA Eastern Colorado Health Care System. The registered enrollment target is 383 participants.

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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.

Interventions

  • OTHER Placebo
  • BIOLOGICAL Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766)

Trial Details

FieldValue
Enrollment Target 383 participants
Start Date 2020-08-24
Est. Completion 2025-12-31
Phase Phase 2

What the Registry Record Tells You About NCT04150380

The ClinicalTrials.gov registry entry for NCT04150380 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 383 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Eastern Colorado Health Care System, which has 42 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04150380 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.