Biological Signatures, Probiotic Among Those With mTBI and PTSD

This is an interventional other trial for Mild Traumatic Brain Injury focused on measuring PTSD, Mild TBI, Probiotic, Inflammation Read More

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

  • Acute disease is defined as the presence of a moderate or severe illness with or without fever
• Chronic, clinically significant (unresolved, requiring on-going medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, as determined by medical history or physical examination other than irritable bowel syndrome (IBS)
• History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
• Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet
• Positive test for human immunodeficiency virus (HIV), Hepatitis B virus, or Hepatitis C virus
• Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection
• Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
• Regular urinary incontinence necessitating use of incontinence protection garments
• Female who is pregnant or lactating
• Treatment for or suspicion of ever having had toxic shock syndrome
• Those receiving immunosuppressive drugs or treatment including antineoplastic therapy, post-transplantation immunosuppressive therapy, and/or radiation therapy