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CTRI Number  CTRI/2018/07/014991 [Registered on: 20/07/2018] Trial Registered Prospectively
Last Modified On: 19/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of probiotic supplementation on feed tolerance and weight gain in low birth weight infants on tube feeds 
Scientific Title of Study   Probiotic supplementation and its effect on feed tolerance and weight gain in low birth weight infants on orogastric feeds- 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  Dr Arzoo Allahabadi  
Designation  Post graduate student  
Affiliation  GGS medical college and hospital faridkot  
Address  Neonatal Intensive Care Unit, Department of pediatrics,GGS medical college and hospital faridkot

Faridkot
PUNJAB
151203
India 
Phone  9914032676  
Fax    
Email  arzooallahabadi29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amarpreet Kaur  
Designation  Associate professor  
Affiliation  GGS medical college and hospital faridkot  
Address  Neonatal Intensive Care Unit, Department of pediatrics,GGS medical college and hospital faridkot

Faridkot
PUNJAB
151203
India 
Phone  9914030677  
Fax    
Email  dr.amarpreet12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amarpreet kaur 
Designation  Associate professor  
Affiliation  GGS medical college and hospital faridkot  
Address  Neonatal Intensive Care Unit, Department of pediatrics,GGS medical college and hospital, faridkot

Faridkot
PUNJAB
151203
India 
Phone  9914030677  
Fax    
Email  dr.amarpreet12@gmail.com  
 
Source of Monetary or Material Support  
Neonatal Intensive Care Unit, Department of pediatrics,GGS medical college and hospital, Sadiq road, Faridkot  
 
Primary Sponsor  
Name  Dr Arzoo Allahabadi  
Address  GGS medical college and hospital faridkot  
Type of Sponsor  Other [Post graduate student ] 
 
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 
Dr Arzoo Allahabadi   GGS medical college and hospital   Neonatal Intensive Care Unit, Department of pediatrics, GGS medical college and hospital faridkot
Faridkot
PUNJAB 		 9914032676

arzooallahabadi29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethics committee of Guru Gobind Singh Medical College and Hospital, Faridkot   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Low birth infants on orogastric feeds,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Probiotic   Probiotic containing lactibacillus acidophilus, lactibacillus rhamnosus, bifidobacterium longum, saccharomyces boulardi in form of powdered sachet of 1g each Dose is 1.25×1000000000 once a day  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All neonates with a birth weight between 1000 to 1800gm admitted to the NICU in whom enteral feeds can be started.  
 
ExclusionCriteria 
Details  Neonates with weight<1000gm.
Neonates with gastrointestinal anomalies.
Neonates with major congenital malformations.
Neonates in whom the feed could not be started by day 14 of life. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the time taken(in days) to reach full enteral feeds(150ml/kg/day) in low birth weight infants on orogastric feeds between the probiotic and no probiotic group.
To compare episodes of feed intolerance and weight gain in both the groups. 		 Time taken to reach full enteral feeds  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the duration of hospital stay, incidence of NEC stage 2 or more, other morbidity and mortality during hospital stay in both the groups.
 		 Duration of hospital stay  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 1 
Date of First Enrollment (India)   31/07/2018 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Establishment of full feeds and feeding management is an emerging challenge in the care of Low birth weight infants.  Probiotics are live microbial supplements that colonize the bowel of these neonates with favourable flora, improve feed tolerance and enhances growth of these infants. However probiotics are not yet used as a standard of care and no study has been done in our area for their use.  Hence this study is planned in which Low birth weight infants will be divided into 2 groups out of which feeds of infants of one group will be supplemented with probiotics and other group will be given only feeds. The two groups will be compared for the role of probiotics in Low birth weight infants in time taken to reach full feeds,  episodes of feed intolerance, weight gain, duration of hospital stay, incidence of NEC stage 2 or more and morbidity and mortality during hospital stay.  
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