Clinical Trial of Oral Supplementation With Novel Mycolicibacterium (MTC 0012)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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