Biological Signatures, Probiotic Among Those With mTBI and PTSD
Biological Signature and Safety of an Immunomodulatory Probiotic Intervention for Veterans With Co-Occurring Mild TBI and PTSD
1 other identifier
interventional
75
1 country
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 30, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedResults Posted
Study results publicly available
July 28, 2020
CompletedAugust 18, 2020
August 1, 2020
2.8 years
March 1, 2016
May 21, 2020
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
C-Reactive Protein Change
Inflammation - Biological Signature (Blood)
Baseline and approximately 10 weeks
Secondary Outcomes (1)
Tumor Necrosis Factor Change
2 weeks and approximately 10 weeks
Other Outcomes (6)
Visual Analog Scale
Approximately 10 weeks
Interleukin 6 Change
2 weeks and approximately 10 weeks
Interleukin 10 Change
2 weeks and approximately 10 weeks
- +3 more other outcomes
Study Arms (2)
L. reuteri
EXPERIMENTALCommercially 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.
Sunflower and medium chain triglyceride oils
PLACEBO COMPARATORSunflower and medium chain triglyceride oils
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
Eligibility Criteria
You may qualify if:
- History of at least one deployment in support of Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF)/Operation New Dawn (OND)
- History of mTBI per the Ohio State University (OSU) TBI-ID85 with any endorsement of post concussive symptoms (PCS) associated with an mTBI, which occurred at least 6 months prior to the baseline assessment
- Current symptoms in 3 or more of the following ICD-10 Post Concussive Symptom86 categories as measured by the Rivermead Post Concussive Symptom Questionnaire (RPCSQ87; score of 2 or greater per symptom to qualify):
- headache
- dizziness
- malaise
- fatigue
- noise intolerance
- irritability
- depression
- anxiety
- emotional lability
- subjective concentration
- memory
- intellectual difficulties
- +7 more criteria
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)
- Current major depressive disorder (MDD)
- 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 antibiotics within the last month; use of topical antibiotics or topical steroids on the face, scalp, or neck or on arms, forearms, or hands within the previous 7 days
- Receiving medications that interfere with gut motility (opiates, loperamide, stool softeners)
- Presence of central venous catheters (CVCs)
- Gastrointestinal (GI) barriers as identified by the 2-week run-in period as determined by the study team (e.g., daily GI discomfort with frequent diarrhea prior to supplementation)
- Participation in conflicting interventional research protocol
- Body mass index (BMI) greater than or equal to 35 or less than or equal to 18
- Vital signs outside of acceptable range, i.e., blood pressure \>160/100, oral temperature \>100 F, pulse \>100
- Use of any of the following drugs within the last 6 months:
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045, United States
Related Publications (1)
Brenner LA, Forster JE, Stearns-Yoder KA, Stamper CE, Hoisington AJ, Brostow DP, Mealer M, Wortzel HS, Postolache TT, Lowry CA. Evaluation of an Immunomodulatory Probiotic Intervention for Veterans With Co-occurring Mild Traumatic Brain Injury and Posttraumatic Stress Disorder: A Pilot Study. Front Neurol. 2020 Oct 20;11:1015. doi: 10.3389/fneur.2020.01015. eCollection 2020.
PMID: 33192959DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Lisa A Brenner
- Organization
- Eastern Colorado Health Care System, Rocky Mountain MIRECC
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa A Brenner, PhD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2016
First Posted
March 30, 2016
Study Start
August 1, 2016
Primary Completion
May 31, 2019
Study Completion
June 1, 2019
Last Updated
August 18, 2020
Results First Posted
July 28, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share