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Probiotic (LGG) for Veterans With PTSD

NCT04150380 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2026-03-24

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766)

See arm descriptions

OTHER

Placebo

See arm descriptions

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • University of Colorado, Boulder

    collaborator OTHER

  • VA Eastern Colorado Health Care System

    lead FED

Principal Investigators

  • Lisa Brenner, Ph.D. · US Department of Veterans Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150380 on ClinicalTrials.gov