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

June 16, 2026 updated by: Kioga Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Enrolled participants reported to the study site to complete onboarding, which included baseline surveys, receipt of their 1-week supply of study supplement, and ingest their first dose of their supplement. The active treatment group received capsules containing 1 mg of KGA-10 and excipient (microcrystalline cellulose) while the placebo group received capsules of excipient only. Participants remained at the study site for two hours to be under the supervision of a medical professional to evaluate and respond to any anaphylactic, allergic, or adverse events (AE). Following the two-hour observation period, participants were cleared for release by the medical professional and provided with the 24 hr contact information (mobile phone number and email address) to reach the study principal investigator (PI) and medical professional. They were then released from the study site with the remaining 1-week supply of their supplement and completed the rest of the trial remotely via the data capture platform. Participants were instructed to seek immediate medical attention for any serious adverse events and to report any additional concerns to the study PI and/or medical professional. Additionally, participants had 24 hr access to an AE reporting mechanism on the data capture platform dashboard. Participants were informed that missed doses were not to be replaced with a double dose the following day.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80301
        • University of Colorado, Boulder - WILD campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KGA-10
1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule
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.
Other Names:
  • Heat-killed whole cell preparation of Mycolicibacterium petrae KGA-10
  • NeuroAlly
  • KGA-10
  • Mycolicibacterium petrae
Placebo Comparator: Placebo
Microcrystalline cellulose in size 1 capsule
Dietary supplement: Placebo (microcrystalline cellulose)
Microcrystalline cellulose in size 1 capsule
Other Names:
  • Microcrystalline Cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability/satisfaction of the treatment relative to placebo group as assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM).
Time Frame: From the first dose to end of the treatment period at day-7
Secondary outcome was supplement satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM; score range: 0 to 100). This metric measures ease of administration of the supplement and participant satisfaction with the supplement with higher scores being attributed to higher tolerability/satisfaction.
From the first dose to end of the treatment period at day-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kioga Inc.

Collaborators

University of Colorado, Boulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2025

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13830-1_KGA-10- Safety

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underlie the results will be made available upon request after signing NDA.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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