CTRI/2022/02/040296
Not yet recruiting
未知
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: N189- Chronic kidney disease, unspecified
- Sponsor
- Dr Vandana Godella
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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