| CTRI Number |
CTRI/2025/12/099898 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| 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 comparing Phototherapy alone and Phototherapy with Probiotic in Neonatal Jaundice |
|
Scientific Title of Study
|
Probiotic as add on to Phototherapy versus Phototherapy alone in Neonatal Hyperbilirubinemia: An Open-label Randomized Controlled Trial. |
| 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 NDVaswani |
| Designation |
Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma PGIMS ROHTAK |
| Address |
Department of Paediatrics
Pandit Bhagwat Dayal Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9466676863 |
| Fax |
|
| Email |
ndvaswani@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Mahajan |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma PGIMS ROHTAK |
| Address |
Department of Paediatrics.
Pandit Bhagwat Dayal Sharma PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
08219001428 |
| Fax |
|
| Email |
mahajanp437@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Mahajan |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma PGIMS ROHTAK |
| Address |
Department of Paediatrics.
Pandit Bhagwat Dayal Sharma PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
08219001428 |
| Fax |
|
| Email |
mahajanp437@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak Haryana 124001,India |
|
|
Primary Sponsor
|
| Name |
Pandit Bhagwat Dayal Sharma PGIMS Rohtak Haryana India |
| Address |
Department of Paediatrics
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak Haryana 124001, India |
| 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 Priya Mahajan |
Pt. Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana |
Department of Paediatrics
Emergency Room-11 PGIMS ROHTAK
Rohtak
HARYANA |
8219001428
mahajanp437@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee ,Pt. B. D. Sharma PGIMS/UHS, Rohtak. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Phototherapy alone |
Phototherapy will be discontinued when bilirubin levels decrease to level below phototherapy range as per AAP 2022 guidelines at 2 intervals |
| Intervention |
Probiotic with Phototherapy |
Probiotic continued with phototherapy till the serum bilirubin level fall below phototherapy cutoff according to AAP guidelines at 2 intervals or maximum for 7 days . |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All neonates with gestational age more than 35 weeks to 41 +6weeks who will reach the threshold for photography according to AAP 2022 guidelines for neonatal hyperbilirubinemia. |
|
| ExclusionCriteria |
| Details |
Preterm neonates more than 35 weeks.
Elevated direct bilirubin levels.
Any clinical or laboratory evidence of infection, any gross congenital malformations, glucose 6-phosphate dehydrogenase deficiency, history of maternal phenobarbital intake.
4. Critically sick neonates undergoing mechanical ventilation or in shock or on vasopressor support.
5. Neonates with critical heart disease, critical renal system anomaly, critical respiratory or gastrointestinal tract disease.
Neonates who previously received phototherapy.
Serum bilirubin levels reached the standard for exchange blood transfusion.
Refusal of consent by parents/guardian.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rate of decline in serum bilirubin levels.
Days of phototherapy.
Duration of hospital stay.
4. Side effects of probiotic.
i. Loose stools
ii. Rash
iii. Feed intolerance
Abdominal distention
Rebound hyperbilirubinemia.
|
Baseline
At 12 hours,24 hours ,48 hours and 72 hours and thereafter as per standardized unit protocol
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/01/2026 |
| 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 Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Neonatal hyperbilirubinemia that causes yellowing of skin , conjuctiva due to raised serum pr plasma bilirubin within 2-3 days of birth It is found in about 60% term and 80% preterm infants during 1st week of life. Due to delayed and insufficient colonization of GI flora in early stage tof neonates .There are few microbiota involved in bilirubin meta bolism resulting in decreased conversation of conjugated bilirubin to stercobilin. U conjugated bilirubin collects in intestine and recirculated leading to increased serum bilirubin level.Adjuvent probiotics in neonatal jaundice treatment is new area of interest for declining serum bilirubin levels along with phototherapy. There will be two groups of neonates allocated via simple randomisation technique First with phototherapy with probiotics and other is phototherapy alone.These modalities will be continued till bilirubin levels fall below phototherapy cutoff at two intervals or max for 7 days or probiotics will be given max. for 7 days .we will assess the role of probiotics on phototherapy duration in neonatal hyperbilirubinemia . |