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

NCT07660107 | Completed DMC

• 1 other identifier: 13830-1_KGA-10- Safety
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Safety; Tolerability

Keywords

KGA-10; Mycolicibacterium petrae; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P)

  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.

  From the first dose to the end of treatment at day 7.

Secondary Outcomes (1)

• Tolerability/satisfaction of the treatment relative to placebo group as assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM).

  From the first dose to end of the treatment period at day-7

Study Arms (2)

KGA-10

EXPERIMENTAL

1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule

Dietary Supplement: Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly)

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose in size 1 capsule

Dietary Supplement: Placebo (microcrystalline cellulose)

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.

Also known as: NeuroAlly, KGA-10, Mycolicibacterium petrae, Heat-killed whole cell preparation of Mycolicibacterium petrae KGA-10

KGA-10

Placebo (microcrystalline cellulose) DIETARY_SUPPLEMENT

Microcrystalline cellulose in size 1 capsule

Also known as: Microcrystalline Cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kioga Inc.: lead
• University of Colorado, Boulder: collaborator

Study Sites (1)

University of Colorado, Boulder - WILD campus

Boulder, Colorado, 80301, United States

Location

Related Publications (9)

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MeSH Terms

Interventions

microcrystalline cellulose

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: July 7, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)