Safety and Tolerability of Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) - a Pilot Study
16. juni 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
8
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Colorado
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Boulder, Colorado, Forenede Stater, 80301
- University of Colorado, Boulder - WILD campus
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: KGA-10
1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule
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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.
Andre navne:
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Placebo komparator: Placebo
Microcrystalline cellulose in size 1 capsule
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Microcrystalline cellulose in size 1 capsule
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P)
Tidsramme: From the first dose to the end of treatment at day 7.
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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.
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From the first dose to the end of treatment at day 7.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tolerability/satisfaction of the treatment relative to placebo group as assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM).
Tidsramme: From the first dose to end of the treatment period at day-7
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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.
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From the first dose to end of the treatment period at day-7
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Hanski I, von Hertzen L, Fyhrquist N, Koskinen K, Torppa K, Laatikainen T, Karisola P, Auvinen P, Paulin L, Makela MJ, Vartiainen E, Kosunen TU, Alenius H, Haahtela T. Environmental biodiversity, human microbiota, and allergy are interrelated. Proc Natl Acad Sci U S A. 2012 May 22;109(21):8334-9. doi: 10.1073/pnas.1205624109. Epub 2012 May 7.
- Farivar SS, Cunningham WE, Hays RD. Correlated physical and mental health summary scores for the SF-36 and SF-12 Health Survey, V.I. Health Qual Life Outcomes. 2007 Sep 7;5:54. doi: 10.1186/1477-7525-5-54.
- Rief W, Barsky AJ, Glombiewski JA, Nestoriuc Y, Glaesmer H, Braehler E. Assessing general side effects in clinical trials: reference data from the general population. Pharmacoepidemiol Drug Saf. 2011 Apr;20(4):405-15. doi: 10.1002/pds.2067. Epub 2010 Nov 8.
- Franzen PL, Buysse DJ, Rabinovitz M, Pollock BG, Lotrich FE. Poor sleep quality predicts onset of either major depression or subsyndromal depression with irritability during interferon-alpha treatment. Psychiatry Res. 2010 May 15;177(1-2):240-5. doi: 10.1016/j.psychres.2009.02.011. Epub 2010 Apr 9.
- Rook GA, Lowry CA, Raison CL. Microbial 'Old Friends', immunoregulation and stress resilience. Evol Med Public Health. 2013 Jan;2013(1):46-64. doi: 10.1093/emph/eot004. Epub 2013 Apr 9.
- Allgire E, McAlees JW, Lewkowich IP, Sah R. Asthma and posttraumatic stress disorder (PTSD): Emerging links, potential models and mechanisms. Brain Behav Immun. 2021 Oct;97:275-285. doi: 10.1016/j.bbi.2021.06.001. Epub 2021 Jun 6.
- Stamper CE, Hoisington AJ, Gomez OM, Halweg-Edwards AL, Smith DG, Bates KL, Kinney KA, Postolache TT, Brenner LA, Rook GA, Lowry CA. The Microbiome of the Built Environment and Human Behavior: Implications for Emotional Health and Well-Being in Postmodern Western Societies. Int Rev Neurobiol. 2016;131:289-323. doi: 10.1016/bs.irn.2016.07.006. Epub 2016 Sep 6.
- von Hertzen L, Beutler B, Bienenstock J, Blaser M, Cani PD, Eriksson J, Farkkila M, Haahtela T, Hanski I, Jenmalm MC, Kere J, Knip M, Kontula K, Koskenvuo M, Ling C, Mandrup-Poulsen T, von Mutius E, Makela MJ, Paunio T, Pershagen G, Renz H, Rook G, Saarela M, Vaarala O, Veldhoen M, de Vos WM. Helsinki alert of biodiversity and health. Ann Med. 2015 May;47(3):218-25. doi: 10.3109/07853890.2015.1010226. Epub 2015 Apr 23.
- Ruokolainen L, von Hertzen L, Fyhrquist N, Laatikainen T, Lehtomaki J, Auvinen P, Karvonen AM, Hyvarinen A, Tillmann V, Niemela O, Knip M, Haahtela T, Pekkanen J, Hanski I. Green areas around homes reduce atopic sensitization in children. Allergy. 2015 Feb;70(2):195-202. doi: 10.1111/all.12545.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
7. juli 2025
Primær færdiggørelse (Faktiske)
15. juli 2025
Studieafslutning (Faktiske)
15. juli 2025
Datoer for studieregistrering
Først indsendt
16. juni 2026
Først indsendt, der opfyldte QC-kriterier
16. juni 2026
Først opslået (Faktiske)
22. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13830-1_KGA-10- Safety
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
IPD that underlie the results will be made available upon request after signing NDA.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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