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

Part of paid clinical trials in Boulder, Colorado.

Sponsor
Kioga Inc.
Study ID
NCT07660107
Status
Completed

Conditions

  • Safety
  • Tolerability

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly) — DIETARY_SUPPLEMENT
    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.
  • Placebo (microcrystalline cellulose) — DIETARY_SUPPLEMENT
    Microcrystalline cellulose in size 1 capsule

Study Details

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.

Key Dates

Start date
Jul 7, 2025
Status verified
Jun 2026
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KGA-10
    1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule
  • Placebo Comparator: Placebo
    Microcrystalline cellulose in size 1 capsule

Primary Outcome Measure

Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P) [ Time Frame: From the first dose to the end of treatment at day 7. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado, Boulder - WILD campusBoulderColorado80301-

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By research site
University of Colorado, Boulder - WILD campus· Boulder, CO

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