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COMPLETED

NCT07660107

Safety and Tolerability of Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) - a Pilot Study

Sponsor: Kioga Inc.

View on ClinicalTrials.gov

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) is safe and well tolerated for healthy adults. 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 and 2) is KGA-10 well tolerated. 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 examine any adverse side effects and tolerability of KGA-10 relative to placebo. Participants will take KGA-10 or a placebo everyday for 1 week and keep a daily log of their supplement intake that includes the time of day. Participants will complete the Generic Assessment of Side Effects - Probiotics (GASE-P)\* survey to assess side effects experienced during the trial both related and not related to the supplement at baseline, 2 hrs following their first dose, 24 hrs following their first dose, and on day-7. Participants will complete the Treatment Satisfaction Questionnaire for Medication (TSQM) survey to assess tolerability/satisfaction of the supplement at 2 hrs following their first dose, 24 hrs following their first dose, and on day-7. \*Survey was modified by replacing the work "probiotic" with "postbiotic" for accuracy.

Official title: Clinical Trial of Oral Supplementation With Novel Mycolicibacterium (KGA-10)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-07

Completion Date

2025-07-15

Last Updated

2026-06-22

Healthy Volunteers

Yes

Conditions

Safety Tolerability

Interventions

DIETARY_SUPPLEMENT

Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly)

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_SUPPLEMENT

Placebo (microcrystalline cellulose)

Microcrystalline cellulose in size 1 capsule

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

Locations (1)

University of Colorado, Boulder - WILD campus

Boulder, Colorado, United States