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CTRI Number  CTRI/2012/08/002853 [Registered on: 03/08/2012] Trial Registered Prospectively
Last Modified On: 05/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study of the Effect of Probiotic organism administration on Feeding Tolerance in Very Low Birth Weight Newborn babies 
Scientific Title of Study   Effect of Probiotics on Feed Tolerance in Very Low Birth Weight Neonates- A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrShashidharA 
Designation  DM neonatology resident 
Affiliation  St.Johns medical college,Rajiv Gandhi University of health Sciences Bangalore 
Address  Senior resident Dept.of Neonatology St.Johns Medical College Koramangala Bangalore

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  shashiishere@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSwarnarekhaBhat 
Designation  Professor and Head 
Affiliation   
Address  Senior resident Dept.of Neonatology St.Johns Medical College Koramangala Bangalore

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  srekha74@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  DrShashidharA 
Designation   
Affiliation   
Address  Senior resident Dept.of Neonatology St.Johns Medical College Koramangala Bangalore

Bangalore
KARNATAKA
560034
India 
Phone    
Fax    
Email  shashiishere@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  DrShashidharA 
Address  Dept of Neonatology St Johns Medical college BANGALORE 
Type of Sponsor  Other [self] 
 
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 
DrShashidharA  Department of NeonatologySt Johns Medical College  Sarjapur Road Koramangala
Bangalore
KARNATAKA 
9916069965

shashiishere@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Review Board  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Primary care givers of high risk neonates. 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  breast milk  breast milk only 
Intervention  probiotic satchets  Lactobacillus Spp,Bifidobacter Spp,Saccharomyces boulardi oral 1 satchet once a day orally mixed in breast milk till discharge 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All neonates (infants in the first 28 days of life) with a birth weight less than 1.5kg, admitted to NICU SJMCH Bangalore. Postnatal age <2wks and started enteral feeds. 
 
ExclusionCriteria 
Details  • Neonates GI tract anomalies, severe congenital malformations.
• Refusal of consent.
• Not started enteral feeds by day 14 of life.
• Outborn babies fed within 72 hrs
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
time to reach full enteral feeds  till discharge 
 
Secondary Outcome  
Outcome  TimePoints 
o incidence of feed intolerance
o incidence of NEC stage 2 or more
o duration of hospital stay
o days on TPN
o weight gain
o mortality
 
till diascharge 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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   Phase 3 
Date of First Enrollment (India)   31/08/2012 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 

 Enteral feeding intolerance is a major problem in premature infants, resulting in prolonged hospitalisation and a predisposition to serious complications due to prolonged use of parenteral nutrition.Second to prematurity, feedings and feeding practices are frequently implicated in the development of necrotizing enterocolitis. Enteral supplementation of probiotics prevents severe NEC and all-cause mortality in preterm infants. Review of available evidence supports a change in practice  Following recent data, many centres are currently supplementing preterm infants routinely with probiotics. 

 

Feeding intolerance has been considered as a precursor of NEC and many strategies have been tried in its prevention.Probiotics by themselves, or stimulated by prebiotic fermentation, are important modulators of the intestinal immune system, helps to produce a balanced T-helper cell response and prevents an imbalance contributing in part to clinical disease. An adequate establishment of the intestinal flora after birth is strictly related to motility maturation and plays a crucial role in the development of gut barrier function and the innate and adaptative immune system. In some RCTs done for prevention of NEC, probiotics have been shown to reduce time to full feeds, hospitalization days and days on total parenteral nutrition (TPN).

 
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