| CTRI Number |
CTRI/2024/07/069824 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| 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 Supplementation on Morbidities in Indian Preterm Neonates. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nehal Athreyi R |
| Designation |
Junior Resident |
| Affiliation |
RNT Medical College & Hospital, Udaipur |
| Address |
Department of Paediatrics
RNT Medical College & Hospital
Near Court circle, Udaipur 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
6361747305 |
| Fax |
|
| Email |
nehalathreyi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohammed Asif |
| Designation |
Prefessor & Head |
| Affiliation |
RNT Medical College & Hospital, Udaipur |
| Address |
Department of Paediatrics
RNT Medical College & Hospital
Near Court circle, Udaipur 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9785056044 |
| Fax |
|
| Email |
rntianasif@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nehal Athreyi R |
| Designation |
Junior Resident |
| Affiliation |
RNT Medical College & Hospital, Udaipur |
| Address |
Department of Paediatrics
RNT Medical College & Hospital
Near Court circle, Udaipur 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
6361747305 |
| Fax |
|
| Email |
nehalathreyi@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNT Medical College & Hospital,
Department of Paediatrics
Near Court Circle
Udaipur - 313001
Rajasthan, India
|
|
|
Primary Sponsor
|
| Name |
RNT Medical College & Hospital, Udaipur |
| Address |
Near Court circle, Udaipur 313001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nehal Athreyi R |
RNT Medical College & Hospital |
Department of Paediatrics
Near Court Circle
Pin Code - 313001
Udaipur
RAJASTHAN |
6361747305
nehalathreyi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNTMedicalCollegeandControllerandAttachedHospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 Neonates born before less than 34weeks
Age at recruitment within 7 days of life
Weight low birth weight less than 1800 grams
|
|
| ExclusionCriteria |
| Details |
Malformation of the gut (omphalocele, gastroschisis, intestinal atresia)
Neonates with central venous catheter
Any condition that prevents oral or nasogastric intake
|
|
|
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 stage 2 or more |
Everyday until the period of hospital stay and further upto 6 weeks of life |
|
|
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 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
26/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Probiotic supplementation in preterm neonates was safe and associated with modest improvements in weight at discharge and follow-up. However, it did not significantly impact NEC, sepsis, mortality, or hospital stay, with gestational age remaining the strongest predictor of outcomes. Probiotics can be safely incorporated into NICU care for preterm neonates to support growth, but their greatest benefit is likely in extremely preterm and high-risk populations. |