Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) for Stress, Sleep, and Inflammation

NCT07604038 | Completed DMC

• 1 other identifier: 13830-2_KGA-10 Intervention
• Study Type: interventional
• Target: 107
• 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) 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

Conditions

Stress Resilience; Systemic Inflammation; General Wellbeing; Sleep Quality; Safety

Keywords

KGA-10; Mycolicibacterium petrae; CRP; C-Reactive Protein; Stress Resilience

Outcome Measures

Primary Outcomes (2)

• Decrease in C-reactive protein (CRP) from baseline at week 8

  Mean percent change from baseline will be calculated and compared between placebo and treatment groups.

  From baseline measurement to completion of treatment at week-8.

• 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 8 weeks

Secondary Outcomes (3)

• 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

• Decrease 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

• Decrease 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

Study Arms (2)

KGA-10

EXPERIMENTAL

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

Dietary Supplement: Mycolicibacterium petrae KGA-10 (heat-killed)

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose in size 1 capsule

Dietary Supplement: Placebo (microcrystalline cellulose)

Interventions

Mycolicibacterium petrae KGA-10 (heat-killed) 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: Heat-killed whole cell preparation of Mycolicibacterium petrae KGA-10

KGA-10

Placebo (microcrystalline cellulose) DIETARY_SUPPLEMENT

Microcrystalline cellulose in size 1 capsule

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, 2) able to provide informed consent, 3) willing to take a daily supplement, 4) willing to complete at-home finger prick - blood spot samples on three occasions, and 5) English speaking.

You may not qualify if:

• \) Inability to adequately respond to questions regarding the informed consent procedure, 2) Currently involved in the criminal justice system as a prisoner or ward of the state, 3) Non-English speaking, 4) Current (past month) alcohol or substance abuse or dependence, 5) Lifetime history of bipolar disorder or psychosis, 6) Receiving intravenous, intramuscular, or oral antibiotics within the last month, 7) Receiving medications that interfere with gut motility (opiates, loperamide, stool softeners), 8) Presence of central venous catheters (CVCs), 9) 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), 10) Participation in conflicting interventional research protocol, 11) 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, 13) 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, 14) Chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic or renal functional abnormality, 15) History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision, 16) Positive test for human immunodeficiency virus (HIV), Hepatitis B virus, or Hepatitis C virus, 17) Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection, 18) 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, 19) Regular urinary incontinence necessitating use of incontinence protection garments, 20) Female who is pregnant or lactating, 21) Treatment for or suspicion of ever having had toxic shock syndrome, 22) Those receiving immunosuppressive drugs or treatment including antineoplastic therapy, post-transplantation immunosuppressive therapy, and/or radiation therapy

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

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

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: May 18, 2026
• First Posted: May 22, 2026
• Study Start: August 14, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)