Safety and Tolerability of Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) - a Pilot Study
16. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
8
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Colorado
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Boulder, Colorado, Spojené státy, 80301
- University of Colorado, Boulder - WILD campus
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
Ostatní jména:
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Komparátor placeba: Placebo
Microcrystalline cellulose in size 1 capsule
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Microcrystalline cellulose in size 1 capsule
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Tolerability/satisfaction of the treatment relative to placebo group as assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM).
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
7. července 2025
Primární dokončení (Aktuální)
15. července 2025
Dokončení studie (Aktuální)
15. července 2025
Termíny zápisu do studia
První předloženo
16. června 2026
První předloženo, které splnilo kritéria kontroly kvality
16. června 2026
První zveřejněno (Aktuální)
22. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 13830-1_KGA-10- Safety
Plán pro data jednotlivých účastníků (IPD)
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ANO
Popis plánu IPD
IPD that underlie the results will be made available upon request after signing NDA.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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