Stress Resilience, Systemic Inflammation, General Wellbeing, Sleep Quality, Safety
Conditions
Keywords
KGA-10, Mycolicibacterium petrae, CRP, C-Reactive Protein, Stress Resilience
Brief summary
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
Interventions
DIETARY_SUPPLEMENTMycolicibacterium petrae KGA-10 (heat-killed)
Heat-killed bacteria are considered postbiotics. At the time of registering this clinical trial, Mycolicibacterium petrae KGA-10 is being consider by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain therefore the proper nomenclature is "Candidatus Mycolicibacterium petrae" KGA-10.
DIETARY_SUPPLEMENTPlacebo (microcrystalline cellulose)
Microcrystalline cellulose in size 1 capsule
Sponsors
Kioga Inc.
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1\) healthy individuals between the ages of 18 and 65, 2) able to provide informed consent, 3) willing to take a daily supplement, 4) willing to complete at-home finger prick - blood spot samples on three occasions, and 5) English speaking.
Exclusion criteria
1\) Inability to adequately respond to questions regarding the informed consent procedure, 2) Currently involved in the criminal justice system as a prisoner or ward of the state, 3) Non-English speaking, 4) Current (past month) alcohol or substance abuse or dependence, 5) Lifetime history of bipolar disorder or psychosis, 6) Receiving intravenous, intramuscular, or oral antibiotics within the last month, 7) Receiving medications that interfere with gut motility (opiates, loperamide, stool softeners), 8) Presence of central venous catheters (CVCs), 9) 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), 10) Participation in conflicting interventional research protocol, 11) Vital signs outside of acceptable range, i.e., blood pressure \>160/100, oral temperature \>100°F, pulse \>100. 12\) 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, 13) 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, 14) Chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, 15) History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision, 16) Positive test for human immunodeficiency virus (HIV), Hepatitis B virus, or Hepatitis C virus, 17) Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection, 18) 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, 19) Regular urinary incontinence necessitating use of incontinence protection garments, 20) Female who is pregnant or lactating, 21) Treatment for or suspicion of ever having had toxic shock syndrome, 22) Those receiving immunosuppressive drugs or treatment including antineoplastic therapy, post-transplantation immunosuppressive therapy, and/or radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in C-reactive protein (CRP) from baseline at week 8 | From baseline measurement to completion of treatment at week-8. | Mean percent change from baseline will be calculated and compared between placebo and treatment groups. |
| Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P) | From the first dose to the end of treatment at 8 weeks | A symptom endorsement on the GASE-P was evaluated as an adverse event if it was "Severe", endorsed as related to the supplement, and not present in the baseline GASE-P evaluation. A serious adverse event was defined as any unexpected event resulting in death, life threatening illness, suicide attempt, hospitalization or prolonged hospitalization, and/or persistent/significant disability resulting from participation in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in perceived stress from baseline over the treatment period of 8 weeks | From the first dose to end of the treatment period at week-8 | Perceived stress is being measured by the perceived stress scale - 10 (PSS-10) with higher scores being attributed to higher perceived stress. |
| Decrease in general wellbeing from baseline over the treatment period of 8 weeks | From the first dose to end of the treatment period at week-8 | General wellbeing is being measured by the 36-Item Short Form Survey (SF-36) with higher score being attributed to better wellbeing. Subdomains will be individually assessed. |
| Decrease in self-reported sleep quality from baseline over the treatment period of 8 weeks | From the first dose to end of the treatment period at week-8 | Sleep quality is being measured by the Pittsburgh Sleep Quality Index (PSQI) with higher score being attributed to worse sleep quality. Subdomains will be individually assessed. |
Countries
United States
Outcome results
None listed