Actively Recruiting
Comparative Effects of Zinc Sulfate and Probiotic Lactobacillus rhamnosus GG on Neonatal Indirect Hyperbilirubinemia Undergoing Phototherapy
Led by Quaid-e-Azam Medical College · Updated on 2025-08-05
110
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Term or near-term neonates
- Age less than 7 days at enrollment
- Bilirubin levels within phototherapy range according to NICE bilirubin threshold charts
- No identifiable pathology
- Tolerating oral feeds
- Parental or guardian written informed consent obtained
You will not qualify if you...
- Positive sepsis screen or clinical signs of infection
- Direct hyperbilirubinemia
- Gastrointestinal malformations
- Oral intolerance
- Requiring mechanical ventilation
- Congenital anomalies
- Parental or guardian refusal to participate in study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Typically 3 to 7 days during phototherapy
Participants receive oral zinc sulfate or probiotic lactobacillus rhamnosus GG daily as an adjuvant to phototherapy.
Daily visits or assessments during phototherapy
Trial Site Locations
Total: 1 location
1
Sadiq Abbasi Hospital, QAMC, Bahawalpur
Bahawalpur, Punjab Province, Pakistan, 63100
Actively Recruiting
Research Team
M
Malik M. Umair Fazal, MBBS, FCPS Paediatrics
D
Dr. Muhammad Anwar, MBBS, FCPS Neonatology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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