Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) for Stress, Sleep, and Inflammation
21 maja 2026 zaktualizowane przez: 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
Przegląd badań
Status
Zakończony
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
107
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Colorado
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Boulder, Colorado, Stany Zjednoczone, 80301
- University of Colorado, Boulder - WILD campus
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
Inne nazwy:
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Komparator placebo: Placebo
Microcrystalline cellulose in size 1 capsule
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Microcrystalline cellulose in size 1 capsule
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Decrease in C-reactive protein (CRP) from baseline at week 8
Ramy czasowe: From baseline measurement to completion of treatment at week-8.
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Mean percent change from baseline will be calculated and compared between placebo and treatment groups.
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From baseline measurement to completion of treatment at week-8.
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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)
Ramy czasowe: From the first dose to the end of treatment at 8 weeks
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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 8 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Decrease in perceived stress from baseline over the treatment period of 8 weeks
Ramy czasowe: From the first dose to end of the treatment period at week-8
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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.
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From the first dose to end of the treatment period at week-8
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Increase in general wellbeing from baseline over the treatment period of 8 weeks
Ramy czasowe: From the first dose to end of the treatment period at week-8
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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.
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From the first dose to end of the treatment period at week-8
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Increase in self-reported sleep quality from baseline over the treatment period of 8 weeks
Ramy czasowe: From the first dose to end of the treatment period at week-8
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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.
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From the first dose to end of the treatment period at week-8
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
14 sierpnia 2025
Zakończenie podstawowe (Rzeczywisty)
15 stycznia 2026
Ukończenie studiów (Rzeczywisty)
15 stycznia 2026
Daty rejestracji na studia
Pierwszy przesłany
18 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
18 maja 2026
Pierwszy wysłany (Rzeczywisty)
22 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
26 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 13830-2_KGA-10 Intervention
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
IPD that underlie the results will be made available upon request after signing NDA.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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