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Actively Recruiting

Phase 2
Age: 0Days - 28Days
All Genders
ID07102836

Comparing Oral Zinc and Probiotics for Treating Indirect Hyperbilirubinemia in Newborns Receiving Phototherapy

Led by Quaid-e-Azam Medical College · Updated on 2025-08-05

110

Participants Needed

1

Research Sites

12 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate and compare the effects of oral zinc sulfate and probiotic Lactobacillus rhamnosus GG supplementation in newborns with indirect hyperbilirubinemia who are receiving phototherapy. The study focuses on how these two treatments may help clear bilirubin and reduce the length of phototherapy in neonates. It is a phase 2 clinical trial sponsored by Quaid-e-Azam Medical College. Newborn participants will be randomly assigned to one of two groups one group will receive oral zinc sulfate syrup providing 5 mg of elemental zinc daily, and the other group will receive daily oral probiotic drops of Lactobacillus rhamnosus GG. Both treatments are given alongside standard phototherapy, following neonatal dosing guidelines. The study will monitor participants from the start of supplementation through the completion of phototherapy, which typically lasts 3 to 7 days. During the study, researchers will regularly measure bilirubin levels to assess the rate of decline while on phototherapy with the added supplement. The trial involves double masking to ensure unbiased results. Participants will be newborns under 7 days old with bilirubin levels appropriate for phototherapy according to NICE guidelines. The study includes parental consent and monitors safety and response throughout the treatment period, ending when phototherapy is completed.

CONDITIONS

Brief Title

COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY

Research Team

M

Malik M. Umair Fazal, MBBS, FCPS Paediatrics

D

Dr. Muhammad Anwar, MBBS, FCPS Neonatology

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