Efficacy and Safety of Nitrophage Forte in Predialysis and Dialysis Patients

Recruiting

• Conditions: Chronic Kidney diseases

• Registration Number: CTRI/2015/09/006181
• Lead Sponsor: Mylin Biotech India Pvt Ltd

Brief Summary

**Detailed Description :**

**Chronic kidney disease (CKD) is a global health issue that has a substantial impact on affected**

**Individuals. The prognosis of dialysis patients is poor with 30 to 50 percent 5 year survival in**

**nondiabetic patients and 25 percent in diabetic patients. Cardiovascular diseaseaccounts for**

**approximately half of death of dialysis partients. Chonic inflammation, which is widely seen in long-**

**term dialysis patients, is associated with malnutrition, atherosclerosis and an increased mortality risk.**

**Inflammatory markers such as C-reactive protein (CRP), IL-6, Il-18 and TNF-alpha, are elevated in**

**dialysis and can predict cardiovascular envent and all-cause mortality.**

**Synbiotics ( combination of Probiotics and Prebiotics) are microorganisms given along with**

**Oligosaccharides that have beneficial properties for the host.  Three described benefits includes**

**suppression of growth or epithelial binding/invasion by pathogenic bacteria, improvement of**

**intestinal barrier function and modulation the immune systems.**

**Several probiotics preparations induce protective cytokines, including IL-10, and suppresses**

**proinflammmatory cytokines, such as TNF-alpha and IL-6. Intestinal microflora is deranged in**

**hemodialysis (HD) patients and Predialysis Patients as an increase in aerobic bacteria such as E.coli**

**and a decrease in anaerobic bacteria such as Bifidobacterium.   One study reported that oral**

**administration  of Bifidobacterium longumm in gastroresistant capsules decreases the the pre-HD**

**serum levels of homocysteine and indoxylsulfhate. Another small-scale study from Japan showed that**

**synbiotics containing lactobacilli and can reduce serum level of p-Cresol in HD patients. High –serum**

**p-cresyl sulfate and indoxyl sulfate levels were associated with overall mortality and cardiovascular**

**disease in HD patients.**

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-04
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1.Patient aged ≥18 to 65 years of both female and male to be included 2.CKD patients with GFR <30 ml/minute 3.HD patients GFR<15ml/minute 4.Stage 3 and Stage 4 & 5 CKD patients 5.Patients who are on Dialysis for at least 3 months from the day of screening and Patients who are not doing well on Dialysis 6.Patient with the ability to provide written informed consent form 7.Patients willing to comply with the protocol requirements.

Exclusion Criteria

• 1.Patients with known hypersensitivity to any of the components of the formulation 2.Patient with history of treatment with NitroPhage Forte 3.Active infectious conditions within the last 30days.
• 4.New York Heart Association (NYHA) Classification Category III and IV Cardiac Insufficiency, Ischaemic Heart Disease, Coronary Insufficiency or any other clinically significant cardiovascular disease.
• 5.Patients who have participated in any clinical trial in the past 1 month.
• 6.Autoimmune disease e.g. SLE/Vasculities 7.Diabetic foot infection patients 8.Pregnant or lactating women.
• 9.Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Quality of life with improvement in nutritional status	6 weeks
•Improvement in Anti inflammatory markers such as TNF α and IL6	6 weeks

Secondary Outcome Measures

Name	Time	Method
•Improvement in Lab Values such as BUN,Creatinine.	• Improvement in Uraemic Pruritus

Trial Locations

Locations (1)

Sapthagiri Institute of Medical Sciences and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Sapthagiri Institute of Medical Sciences and Research Centre

🇮🇳Bangalore, KARNATAKA, India

DrSanjay Srinivasa

Principal investigator

080-28393392

drsanjaysrinivas@yahoo.co.in