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

Not yet recruiting

• Conditions: Chronic kidney disease, unspecified,

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

Brief Summary

The study will be carried out after the approval from the NIMS Institutional Ethics Committee. Volunteers will be screened and enrolled after obtaining written informed consent. Eligible patients will be included into the study as per the inclusion and exclusion criteria. Volunteers’ subjects will be enrolled into two groups, study group and control group in a ratio of 4 :1. Standard of care treatment will be given to both the two groups according to Nephrologist which will be monitored throughout the study duration.To study group ,Tab.Renadyl will be administered after treatment initiation every day twice daily after food for 6 months.Primary outcomes like uremic toxin levels such as indoxyl sulfate,indole-3-acetic acid and p-cresyl sulfate,Renal function tests such as blood urea,serum creatinine and serum uric acid and secondary outcomes like inflammatory biomarkers such as hs CRP,IL6,TNF alpha,oxidative stress biomarkers such as MDA,GSH,NO,eGFR ,SF8 and safety of Renadyl are assessed in every visit.

There will be in total 8 visits with screening at day -7 to -1(visit 1), treatment initiation at day 0 with Renadyl tab (visit 2), follow up every 30 days (visits from 3 to 7) and end of study at day 180 (visit 8). The study participants are encouraged to visit the site at any point of time during study period. The study participants are advised to follow the same diet throughout the duration of study. Subject diary will be given for all subjects (study group and control group) recording the consumption of medication and diet which will be reviewed in every visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-18
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 44

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.
• 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.
• 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.	every 30 days for 6 months after enrollment
2. Changes in Renal function tests (Serum urea, creatinine and uric acid) from baseline.	every 30 days for 6 months after enrollment

Secondary Outcome Measures

Name	Time	Method
1.Quality of Life (QoL) SF 8 Questionnaire score	2. hs CRP, IL-6, TNF-α (Inflammatory Biomarkers)

Trial Locations

Locations (1)

Nizams Institute of Medical Sciences; 🇮🇳 Hyderabad, TELANGANA, India

Nizams Institute of Medical Sciences

🇮🇳Hyderabad, TELANGANA, India

Dr Vandana Godella

Principal investigator

9908958157

kvandana.diesel@gmail.com