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A study comparing Phototherapy alone and Phototherapy with Probiotic in Neonatal Jaundice

Probiotic as add on to Phototherapy versus Phototherapy alone in Neonatal Hyperbilirubinemia: An Open-label Randomized Controlled Trial. - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099898
Enrollment
100
Registered
2025-12-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system

Interventions

Intervention1: 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 fo

Sponsors

Pandit Bhagwat Dayal Sharma PGIMS Rohtak Haryana India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: Baseline At 12 hours,24 hours ,48 hours and 72 hours and thereafter as per standardized unit protocol

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Priya Mahajan

Pandit Bhagwat Dayal Sharma PGIMS ROHTAK

mahajanp437@gmail.com08219001428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026