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Safety and Tolerability of Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) - a Pilot Study

2026년 6월 16일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

8

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Colorado
      • Boulder, Colorado, 미국, 80301
        • University of Colorado, Boulder - WILD campus

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: KGA-10
1 mg of KGA-10 mixed with microcrystalline cellulose in size 1 capsule
건강 보조 식품: Heat-killed Mycolicibacterium petrae KGA-10 (NeuroAlly)
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.
다른 이름들:
  • Heat-killed whole cell preparation of Mycolicibacterium petrae KGA-10
  • NeuroAlly
  • KGA-10
  • Mycolicibacterium petrae
위약 비교기: Placebo
Microcrystalline cellulose in size 1 capsule
건강 보조 식품: Placebo (microcrystalline cellulose)
Microcrystalline cellulose in size 1 capsule
다른 이름들:
  • 미정질 셀룰로오스

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of participants with treatment-related adverse events and serious adverse events as assessed by the Generic Assessment of Side Effects - Probiotics (GASE-P)
기간: From the first dose to the end of treatment at day 7.
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 day 7.

2차 결과 측정

결과 측정
측정값 설명
기간
Tolerability/satisfaction of the treatment relative to placebo group as assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM).
기간: From the first dose to end of the treatment period at day-7
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.
From the first dose to end of the treatment period at day-7

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Kioga Inc.

협력자

University of Colorado, Boulder

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 7월 7일

기본 완료 (실제)

2025년 7월 15일

연구 완료 (실제)

2025년 7월 15일

연구 등록 날짜

최초 제출

2026년 6월 16일

QC 기준을 충족하는 최초 제출

2026년 6월 16일

처음 게시됨 (실제)

2026년 6월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 16일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 13830-1_KGA-10- Safety

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Placebo (microcrystalline cellulose)에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Nigeria

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다