Pilot-Scale Clinical Trials of Kibow Biotics® (a Patented and Proprietary Probiotic Formulation) in Chronic Kidney Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kibow Pharma
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid
研究概览
简要总结
The bowel can serve as a complement to the kidneys' excretory function
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been called "enteric dialysis"® Confirm the alleviation of uremic syndrome hypothesis Determine the outcome of probiotics treatment Confirm U.S. FDA's Generally Recognized As Safe (GRAS) status - if needed
详细描述
Probiotics are increasingly utilized clinically. As their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens.
Following exploratory testing of orally administered probiotic bacteria in rats and minipigs with surgically induced chronic kidney disease (CKD), a trial is now in progress to determine whether daily treatment with gastrointestinal (GI) probiotic bacteria will delay the onset of and/or improve established signs and symptoms of human CKD.
To assess the potential benefit in devising a gut-based probiotic formulation (Kibow Biotics®) as a dieatary supplement - Over The Counter (OTC)product in CKD applications.
Extensive in vitro R&D investigations in Kibow's laboratories
Simulated Human Intestinal Microbial Ecosystem (SHIME, Ghent University, Belgium) utilized in a computer-controlled in vitro system validated the concept that the chosen microbial formulation would metabolize and reduce concentration of nitrogenous components including urea, creatinine, and uric acid. Bacterial strains studied were Streptococcus thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD patients Stage III and IV
- •18 to 75 years old, able and willing to give an informed consent
- •Baseline serum creatinine > 2.5 mg/dL
排除标准
- •Women who are pregnant or nursing
- •Patients who are on antibiotic treatment at the time of screening will be excluded from the study (Patients who have received antibiotics should have stopped them for at least 14 days prior to screening)
- •Patients who do not agree to sign the informed consent form
- •Active dependency on drugs or alcohol
- •Patients with documented Human Immunodeficiency Virus (HIV) infection/ Acquired Immunodeficiency Syndrome (AIDS)/Liver Disease
- •Any medical, psychiatric, debilitating disease/disorder or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent, or affect the overall prognosis of the patient
- •Patients who are on coumadin therapy
结局指标
主要结局
PRIMARY: Changes in blood chemistry - BUN, Creatinine and Uric acid
时间窗: six months
Changes in BUN, Creatinine and uric acid levels
时间窗: six months
次要结局
未报告次要终点