A controlled randomized study to evaluate the effect of probiotic on uremic solutes,inflammatory status and oxidative stress in chronic kidney disease subjects - PRO-URE-CKD

Dr Vandana Godella0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

暂无简介。

•1.Either gender >18 to <65 years (both inclusive)
•2.Subjects diagnosed with CKD and have been stable for at least 3 months
•3.Serum creatinine levels greater than 2.5 mg/dL at the time of screening.
•4. Ability to comprehend the full nature and purpose of the study, including possible risks and adverse events; ability to co-operate with the Investigator and to comply with the requirements of the entire study
•5. Willing to sign the written informed consent prior to inclusion in the study at the time of screening.

•1.Pregnant or Nursing women,
•2.Antibiotic treatment at the time of screening or within 14 days before screening
•3.H/o of positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or Hepatitis C in the last 6 months.
•4.Active dependency on controlled substances and alcohol
•5.Administration of an investigational drug either currently or within 30 days of screening.
•6.Active addictive drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment.
•7.Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
•8.Pre-existing cardiac or pulmonary or hepatic or neurological co-morbidities which in the judgement of the Nephrologist would interfere with the study.
•9.Subjects with social conditions or medical debilitating disease/disorder, which, 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 overall prognosis of the Subject.

发起方

Dr Vandana Godella