Abstract: PO2628
A Prospective, Double-Blind, Randomized, Placebo-Controlled Interventional Study to Evaluate the Safety and Efficacy of Enzobiotics in Pre-Dialysis CKD Patients
Session Information
- Late-Breaking Clinical Trials Posters
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 10:00 AM
Category: Health Maintenance, Nutrition, and Metabolism
- 1300 Health Maintenance, Nutrition, and Metabolism
Authors
- Saxena, Anita, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
- Jacob., Chakko Korula, Baptiste hospital -, Bangalore, Karnataka, India
- Sreenivasa, Sanjay, Saptagiri Institute of Medical science, Bangalore, Karnataka, India
- Veerappan, Ilangovan, KG Hospital, Coimbatore, Tamil Nadu, India
- Mahaldar, Amol Ramesh, Vision and Manipal Hospitals ., GOA, Goa, India
- Gupta, Amit, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
- Rajagopal, Anantha subramani, Indian Statistical Institute Delhi Centre, Coimbatore, Tamilnadu, India
Background
Synbiotics and proteolytic enzymes supplemented in CKD prevent formation of uremic toxins (UT) generated by undigested protein.
Aim : Affect of Enzobiotics in reducing generation of P-Cresols and Indoxylsulfhate and quality of life in pre dialysis patients.
Methods
Double blind, randomized, placebo controlled multicentric clinical trial CTRI/2019/01/017070 conducted over 90 Days. Eighty CKD stages 3-5 ND subjects from 5 centers divided into two groups of 40 each: group A received 1 Enzobiotic capsule TID, Group B 1 placebo capsules TID, for three months 5 minutes before food. Blood samples taken on visits 1 and 4 to measure serum creatinine, p- cresols , indoxyl sulphate (IS), platelet count (PC) hsCRP etc.
Results
Placebo increased p-cresol by 21% while drug reduced by 23%. Enzobiotic reduced indoxyl sulfate by 500 µg/ml (from 17200 to below 16700) with reductiion in creatinine. The potential patients above p-cresol level of 20 mg/lt between drug and placebo after 90 days were found to be 53% for placebo against 33% for drug. If testing is not available, Indoxyl sulfate and p-Cresol can be predicted by 2 equations (applied for patency)
SF36 standard questionnaire revealed improvement in quality of life of treatment group. Adversity ratio reduced significantly from 0.3362 to 0.1736 P-Value 0.000 over 90 days. Daily activity limitation, emotional problems and general health reduced adversity from 60% to 47% (5.6%) 50% to 30%, 49% to 19% respectively.
Conclusion
Enzobiotics improve make gut microbiome favourable, can delay dialysis in CKD patients by reducing uremic toxins, CRP, thrombocytopenia and improve cardiac performance, lipid profile, and quality of life.
Funding
- Commercial Support –