General Wellbeing, Safety, Sleep Quality, Stress Resilience, Systemic Inflammation
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
* 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
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; score range: 0 to 40) with higher scores being attributed to higher perceived stress. |
| Increase 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; score range: 0 to 100) with higher score being attributed to better wellbeing. Subdomains will be individually assessed. |
| Increase 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; score range: 0 to 21) with higher score being attributed to worse sleep quality. Subdomains will be individually assessed. |
Countries
United States
Outcome results
None listed