Biological Signatures, Probiotic Among Those With mTBI and PTSD

PHASE1CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

August 1, 2016

Primary Completion Date

May 31, 2019

Study Completion Date

June 1, 2019

Conditions
Mild Traumatic Brain InjuryPost Traumatic Stress Disorder
Interventions
DIETARY_SUPPLEMENT

of Lactobacillus reuteri (L. reuteri; DSM 17938)

Commercially available L. reuteri (deposited in the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ) and referenced as DSM 17938; Gerber Soothe Colic Drops, 100 million CFU/5 drops; formerly known as L. reuteri ATCC 55730) will be used in the proposed study. L. reuteri (phylum Firmicutes) is a gram-positive anaerobic commensal bacteria found in the gut microbiome of humans. Independent testing of the viability of the commercial product will be conducted in our laboratories by diluting drops, plating on agar in triplicate, and anaerobic culturing at 37 oC. The commercial strain (DSM 17938) has been used to improve intestinal functions in infants and reduce symptoms of infantile colic.

OTHER

Sunflower and medium chain triglyceride oils

Placebo

Trial Locations (1)

80045

Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora

All Listed Sponsors
lead

VA Office of Research and Development

FED

NCT02723344 - Biological Signatures, Probiotic Among Those With mTBI and PTSD | Biotech Hunter | Biotech Hunter