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

21 mai 2026 mis à jour par: Kioga Inc.

Clinical Trial of Oral Supplementation With Novel Mycolicibacterium (MTC 0012)

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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

107

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Colorado
      • Boulder, Colorado, États-Unis, 80301
        • University of Colorado, Boulder - WILD campus

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: KGA-10
1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule
Complément alimentaire: Mycolicibacterium petrae KGA-10 (heat-killed)
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.
Autres noms:
  • Heat-killed whole cell preparation of Mycolicibacterium petrae KGA-10
Comparateur placebo: Placebo
Microcrystalline cellulose in size 1 capsule
Complément alimentaire: Placebo (microcrystalline cellulose)
Microcrystalline cellulose in size 1 capsule

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Decrease in C-reactive protein (CRP) from baseline at week 8
Délai: From baseline measurement to completion of treatment 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)
Délai: From the first dose to the end of treatment at 8 weeks
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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Decrease in perceived stress from baseline over the treatment period of 8 weeks
Délai: From the first dose to end of the treatment period at week-8
Perceived stress is being measured by the Perceived Stress Scale - 10 (PSS-10; score range: 0 to 40) with higher scores being attributed to higher perceived stress.
From the first dose to end of the treatment period at week-8
Increase in general wellbeing from baseline over the treatment period of 8 weeks
Délai: From the first dose to end of the treatment period at week-8
General wellbeing is being measured by the 36-Item Short Form Survey (SF-36; score range: 0 to 100) with higher score being attributed to better wellbeing. Subdomains will be individually assessed.
From the first dose to end of the treatment period at week-8
Increase in self-reported sleep quality from baseline over the treatment period of 8 weeks
Délai: From the first dose to end of the treatment period at week-8
Sleep quality is being measured by the Pittsburgh Sleep Quality Index (PSQI; score range: 0 to 21) with higher score being attributed to worse sleep quality. Subdomains will be individually assessed.
From the first dose to end of the treatment period at week-8

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Kioga Inc.

Collaborateurs

University of Colorado, Boulder

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 août 2025

Achèvement primaire (Réel)

15 janvier 2026

Achèvement de l'étude (Réel)

15 janvier 2026

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 13830-2_KGA-10 Intervention

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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