Probiotic (LGG) for Veterans With PTSD

NCT04150380 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 19-2415
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 1

Brief 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

Post Traumatic Stress Disorder; Inflammation

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of C-reactive protein (CRP)

  Blood biomarker of inflammation

  Change from basline to directly following the 8 week intervention

Secondary Outcomes (6)

• PTSD symptoms per the PTSD Checklist for DSM-5 (PCL-5)

  Change from basline to directly following the 8 week intervention

• Type and abundance measurement of gut microbiota

  Change from basline to directly following the 8 week intervention

• Plasma concentration of intestinal permeability

  Change from basline to directly following the 8 week intervention

• Plasma concentration of inflammatory markers

  Change from basline to directly following the 8 week intervention

• Biological and psychological stress response

  Immediately post-intervention

Study Arms (2)

Supplement

EXPERIMENTAL

8 weeks of dietary augmentation with oral LGG 1.0 x 1010 colony forming units (CFU) once daily (delivered in a size 1 capsule)

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

Placebo

PLACEBO COMPARATOR

8 weeks of dietary augmentation with placebo once daily (delivered in a size 1 capsule)

Other: Placebo

Interventions

Placebo OTHER

See arm descriptions

Placebo

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

See arm descriptions

Supplement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• History of at least one deployment in support of OEF/OIF
• Current diagnosis of PTSD per the Clinician Administered PTSD Scale-5 (CAPS-5)
• Current diagnosis of Functional Bowel Disorder by ROME IV
• CRP level of 1.0 mg/L or above at baseline
• Medical clearance to participate by study providers
• Age between 18 and 60
• Ability to provide informed consent
• Willingness to abstain from probiotic supplements (pills, tablets, oils, foods, etc.) other than the investigational product provided until all study procedures are completed
• Willingness to provide blood and stool samples

You may not qualify if:

• Inability to adequately respond to questions regarding the informed consent procedure
• Currently involved in the criminal justice system as a prisoner or ward of the state
• Non-English speaking
• Current (past month) alcohol or substance abuse or dependence
• Lifetime history of bipolar disorder or psychosis or anxiety disorders (excluding PTSD).
• Consistent (e.g., 5x/week or greater) probiotic supplementation within the last month, including probiotic food products such as yogurt, as determined by phone screen interview and Probiotic Food Check List
• Receiving intravenous, intramuscular, or oral antibiotics within the last month
• Presence of central venous catheters (CVCs)
• Gastrointestinal (GI) barriers as identified by the 2-week run-in period as determined by the study team
• Participation in conflicting interventional research protocol
• Vital signs outside of acceptable range, i.e., blood pressure \>160/100, pulse \>100
• Use of any of the following drugs within the last 6 months: antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, or inhaled corticosteroids; cytokines or cytokine inhibitors; methotrexate or immunosuppressive cytotoxic agents
• Acute disease at the time of enrollment (defer sampling until the participant recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever (e.g., oral temperature \>100° F)
• History of cancer
• Unstable dietary history as determined by the PIs (e.g., major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet)

Sponsors & Collaborators

• VA Eastern Colorado Health Care System: lead
• University of Colorado, Denver: collaborator
• University of Colorado, Boulder: collaborator

Study Sites (1)

VA Rocky Mountain Regional Center

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Inflammation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Brenner, Ph.D.

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the VHA Rocky Mountain MIRECC

Model Details: longitudinal, double blind, randomized placebo-controlled design

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: November 4, 2019
• Study Start: August 24, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)