Biological Signatures, Probiotic Among Those With mTBI and PTSD

Completed · Phase 1 · Has a placebo group

Conditions studied: Mild Traumatic Brain Injury, Post Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT02723344

Run by

VA Office of Research and Development

People needed

75

Starts

2016-08-01

Expected to finish

2019-06-01

Last updated by the study team

2020-08-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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
• and/or insomnia
• Current diagnosis of PTSD per the Clinician Administered PTSD Scale-5 (CAPS-5)88
• Medical clearance by study physicians to participate in the protocol
• Age between 18 and 50
• Ability to provide informed consent
• Willingness not to take probiotic supplements (pills, tablets, oils, etc.) other than the product provided in the clinical study until all study procedures are completed
• Willingness to provide blood, as well as 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)
• 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:
• systemic antibiotics
• antifungals
• antivirals or antiparasitics (intravenous, intramuscular, or oral)
• oral
• intravenous
• intramuscular
• nasal or inhaled corticosteroids
• cytokines or cytokine inhibitors
• methotrexate or immunosuppressive cytotoxic agents
• Acute disease at the time of enrollment (defer sampling until subject recovers)

Where it is running

• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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