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CTRI Number  CTRI/2015/09/006181 [Registered on: 14/09/2015] Trial Registered Retrospectively
Last Modified On: 12/09/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Single Arm Study 
Public Title of Study   Efficacy and Safety of Nitrophage Forte in Predialysis and Dialysis Patients 
Scientific Title of Study   A prospective ,Open Label,Observational Study to evaluate the Efficacy and Safety of Nitrophage Forte in Predialysis and Dialysis Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIFTY/CR-0102,V-1.0 dated 12.Sep.2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PrabhakaranP 
Designation  Sales Manager 
Affiliation  Mylin Biotech 
Address  #291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079

Bangalore
KARNATAKA
560 079
India 
Phone  080-23284955  
Fax  080-23284955  
Email  p.prabhakaran@mylinbiotech.com  
 
Details of Contact Person
Scientific Query
 
Name  PrabhakaranP 
Designation  Sales Manager 
Affiliation  Mylin Biotech 
Address  #291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079

Bangalore
KARNATAKA
560 079
India 
Phone  080-23284955  
Fax  080-23284955  
Email  p.prabhakaran@mylinbiotech.com  
 
Details of Contact Person
Public Query
 
Name  PrabhakaranP 
Designation  Sales Manager 
Affiliation  Mylin Biotech 
Address  #291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079

Bangalore
KARNATAKA
560 079
India 
Phone  080-23284955  
Fax  080-23284955  
Email  p.prabhakaran@mylinbiotech.com  
 
Source of Monetary or Material Support  
Mylin Biotech India Pvt Ltd,#291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079 
 
Primary Sponsor  
Name  Mylin Biotech India Pvt Ltd 
Address  #291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSanjay Srinivasa  Sapthagiri Institute of Medical Sciences and Research Centre  #15,Chikkasandra,Hesaragatta Main Road,Bangalore-560090
Bangalore
KARNATAKA 
080-28393392
080-22188737
drsanjaysrinivas@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sapthagiri Institute of Medical Sceinces and Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Kidney diseases ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Nitrophage Forte  45 days Twice daily before 30 minutes of food for patients who are on Dialysis Trice daily before 30 minutes of food for predialysis patients 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
• Quality of life with improvement in nutritional status
• Improvement in Anti inflammatory markers such as TNF α and IL6
 
6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• Improvement in Lab Values such as BUN,Creatinine.
• Improvement in Uraemic Pruritus
 
6 weeks 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/04/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 
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