Observational Clinical Trials of Kibow Biotics (a Patented and Proprietary Probiotic Dietary Supplement) in Chronic Kidney Failure Patients, in Conjunction With Standardized Care of Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Kibow Pharma
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- 15-20% Changes in BUN.
研究概览
简要总结
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing standardized care of treatment for their CKD stage 3 and stage 4 conditions.
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, as a dietary supplement.
Extensive in vitro R&D investigations in Kibow's laboratories
Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).
Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University, Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr) levels.
Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA.
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
- •Age 18 to 75 years
- •CKD Stages 3 and 4 as documented by prior medical history
- •Serum Creatinine >2.5 mg/dL
- •Stable and on CKD status 3 and 4 at least for a year or more
排除标准
- •Pregnant or nursing women
- •Refusal to sign the informed consent form
- •Documented to have HIV/AIDS/Liver disease
- •Active dependency on drugs or alcohol
- •Any non-related medical, debilitating disease/disorder that would interfere with adherence to this study
- •Currently on anticoagulant therapy
结局指标
主要结局
15-20% Changes in BUN.
时间窗: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months.
15-20% Change in Creatinine
时间窗: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
次要结局
- Quality of life outcome based on questionnaire.(Baseline, 1 month, 2 months, 3 months, 4 months, 6 months)
- To observe inflammatory and oxidative stress biomarkers.(Baseline, 1 month, 2 months, 3 months, 4 months, 6 months)
- Observation and analysis of patient fecal matter.(Baseline, 1 month, 2 months, 3 months, 4 months, 6 months)