A study to assess the effect of probiotic in prevention of progression of kidney disease in patients with chronic kidney disease

Not Applicable

• Conditions: Health Condition 1: N189- Chronic kidney disease, unspecified

• Registration Number: CTRI/2022/02/040296
• Lead Sponsor: Dr Vandana Godella

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Uremic toxins plasma levels: Changes in indoxyl sulfate, p-cresyl sulfate and indole-3- acetic acid from baseline are recorded. <br/ ><br>2. Changes in Renal function tests (Serum urea, creatinine and uric acid) from baseline. <br/ ><br> <br/ ><br>Timepoint: every 30 days for 6 months after enrollment

Secondary Outcome Measures

Name	Time	Method
1.Quality of Life (QoL) SF 8 Questionnaire score <br/ ><br>2. hs CRP, IL-6, TNF-α (Inflammatory Biomarkers) <br/ ><br>3. NO, MDA, GSH (Biomarkers of Oxidative stress) <br/ ><br>4. Estimated Glomerular Filtration (eGFR) <br/ ><br>5.Evaluation of safety of study drugsTimepoint: every 30 days for 6 months after enrollment