At a glance
ClinicalIndex Comparison Record- ✓History of at least one deployment in OEF/OIF/OND
- ✓History of mild TBI (mTBI) with post-concussive symptoms occurring ≥6 months prior to baseline
- ✓Current symptoms in 3 or more post-concussive symptom categories (headache, dizziness, malaise, fatigue, noise intolerance, irritability, depression, anxiety, emotional lability, subjective concentration, memory, intellectual difficulties, insomnia)
- ✓Current diagnosis of PTSD per CAPS-5
- ✕Current (past month) alcohol or substance abuse or dependence
- ✕Lifetime history of bipolar disorder, psychosis, or anxiety disorders (excluding PTSD)
- ✕Current major depressive disorder (MDD)
- ✕Consistent probiotic supplementation (≥5x/week) within the last month or use of probiotic food products
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Biological Signature and Safety of an Immunomodulatory Probiotic Intervention for Veterans With Co-Occurring Mild TBI and PTSD
In Brief
A Phase 1 clinical trial evaluating of Lactobacillus reuteri (L. reuteri; DSM 17938) and Sunflower and medium chain triglyceride oils for Mild Traumatic Brain Injury and Post Traumatic Stress Disorder. Completed, enrolled 75 participants across 1 site.
Detailed 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 co-occurring mild TBI (mTBI) and post-traumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic to treat chronic symptoms associated with co-occurring mTBI and PTSD among Veterans. By looking at the impact of probiotic supplementation on biological signatures of increased inflammation, as reflected by the gut microbiota, gut permeability, and biomarkers of peripheral inflammation, this study may lead to the identification of a novel intervention for the treatment of symptoms associated with these frequently co-occurring conditions.
Study Details
Timeline
Interventions
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.
Placebo