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CTRI Number  CTRI/2024/01/062023 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 26/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of oral probiotics supplementation on illnesses in newborns born premature (before 36 weeks of gestation) 
Scientific Title of Study   To study the effect of probiotics preparation Infloran® supplementation in on morbidities in Indian preterm neonates (PrISM) 
Trial Acronym  PrISM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhadresh R Vyas 
Designation  Professor and HOD 
Affiliation  M P Shah Medical College and G G Hospital, Jamnagar 
Address  M P Shah Medical College and G G Hospital
Department of Pediatrics, & hEAD M P shah Government medical college, Jamnagar (Gujarat) Pin code 361008
Jamnagar
GUJARAT
361009
India 
Phone  9825096054  
Fax    
Email  bhadreshrvyas@yahoo.co.uk  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhadresh R Vyas 
Designation  Professor and HOD 
Affiliation  M P Shah Medical College and G G Hospital, Jamnagar 
Address  M P Shah Medical College and G G Hospital
Department of Pediatrics, & hEAD M P shah Government medical college, Jamnagar (Gujarat) Pin code 361008
Jamnagar
GUJARAT
361009
India 
Phone  9825096054  
Fax    
Email  bhadreshrvyas@yahoo.co.uk  
 
Details of Contact Person
Public Query  
Name  Dr Bhadresh R Vyas 
Designation  Professor and HOD 
Affiliation  M P Shah Medical College and G G Hospital, Jamnagar 
Address  M P Shah Medical College and G G Hospital
Department of Pediatrics, & hEAD M P shah Government medical college, Jamnagar (Gujarat) Pin code 361008
Jamnagar
GUJARAT
361009
India 
Phone  9825096054  
Fax    
Email  bhadreshrvyas@yahoo.co.uk  
 
Source of Monetary or Material Support  
M P Shah Medical College and G G Hospital, M P shah Government medical college, Jamnagar (Gujarat) Pin code 361008 
 
Primary Sponsor  
Name  Dr Nandini Desai Principle 
Address  Pathologist, M P Shah Medical College and G G Hospital, Jamnagar Gujarat 
Type of Sponsor  Government medical college 
 
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 Bhadresh R Vyas  M P Shah Medical College and G G Hospital  Department of Pediatrics, & hEAD M P shah Government medical college, Jamnagar (Gujarat) Pin code 361008
Jamnagar
GUJARAT 		 9825096054

bhadreshrvyas@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC MP Shah Govt Medical College and Guru Gobindsingh Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K553||Necrotizing enterocolitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Probiotic preparation Infloran®  containing probiotics including Lactobacillus Acidophilus 1.0000 billion CFU and Bifidobacterium Bifidum 1.0000 billion CFU in each capsule Study Duration-10 Months 
Comparator Agent  Standard care without probiotics supplementation  Standard care without probiotics supplementation Study duration 10 Months 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  Gestation: Preterm infants and neonates born at 32 weeks gestation or 32 to 36 weeks gestation

Age at recruitment: within 7 days of age
Weight: very low birth weight or lessthan 1500 grams
Gender any
 
 
ExclusionCriteria 
Details  Severe birth complications
Malformation of the gut (omphalocele, gastroschisis, intestinal atresia)
Chromosomal anomalies
Neonates with central venous catheter
Neonates on antifungal drugs
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
suspected or confirmed positive Bell state II or more (1)(2)   Day 42 after the birth 
 
Secondary Outcome  
Outcome  TimePoints 
Culture positive sepsis: blood culture positive
Clinical sepsis: clinical features of sepsis without positive blood culture
 		 Day 42 after the birth 
All-cause mortality  Day 42 after the birth 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/02/2024 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data available at study site for 5 years

  6. For how long will this data be available start date provided 16-01-2024 and end date provided 31-10-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Preterm infants born at the study site hospitals or referred to these hospitals will be enrolled in the study, if they satisfy all inclusion criteria and meet none of the exclusion criteria.

 
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