Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) for Stress, Sleep, and Inflammation

Clinical Trial of Oral Supplementation With Novel Mycolicibacterium (MTC 0012)

The goal of this clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain "Candidatus Mycolicibacterium petrae" KGA-10 (KGA-10) has effects on perceived stress, systemic inflammation, self-reported measures of sleep, and self-reported general well-being in healthy adults. This clinical trial will also learn about safety and tolerability of KGA-10. This novel Mycolicibacterium species is also referred to as NeuroAlly and MTC 0012. The questions it aims to answer are: 1) is KGA-10 associated with adverse side effects; 2) does KGA-10 reduce systemic inflammation; 3) does KGA-10 reduce perceived stress; 4) does KGA-10 improve self -reported measures of sleep; 4) does KGA-10 improve self-reported metrics of general wellbeing.

Researchers will compare daily KGA-10 (1 mg mixed with microcrystalline cellulose in capsule form) to a placebo (microcrystalline cellulose in capsule form, but contains no KGA-10) to see if KGA-10 has effects on the proposed outcomes.

Participants will take KGA-10 or a placebo everyday for 8 weeks and keep a daily log of their supplement intake that includes the time of day. Participants will complete a weekly survey to assess side effects experienced during the trial both related and not related to the supplement. They will complete additional weekly surveys evaluating perceived stress and self-reported measures of sleep. They will complete a survey evaluating self-reported general well-being and provide dried blood spot (DBS) samples to assess systemic inflammation at baseline, week-4, and week-8

Inclusion Criteria:

• Healthy individuals between the ages of 18 and 65
• Able to provide informed consent
• Willing to take a daily supplement
• Willing to complete at-home finger prick - blood spot samples on three occasions
• English speaking

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
• Receiving intravenous, intramuscular, or oral antibiotics within the last month
• 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
• 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 the participant recovers-acute disease is defined as the presence of a moderate or severe illness with or without fever)
• Chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality
• History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision
• 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