A Phase 2 interventional study of Zinc sulfate and Probiotic lactobacillus rhamnosus GG in Indirect Hyperbilirubinemia and Neonatal, sponsored by Quaid-e-Azam Medical College. Recruiting at 1 site in Pakistan. Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Quaid-e-Azam Medical College · Phase 2, Interventional, and Treatment
Study will evaluate effects of oral zinc and probiotics supplementation in neonates who have indirect hyperbilirubinemia and are receiving phototherapy. Aim is to compare efficacy of these two drugs in clearing bilirubin and reducing duration of phototherapy. Neonates will be randomly assigned to receive either drug alongside phototherapy.
84 studies on the registry are indexed under Jaundice; 13 are open to participants now.
This study's planned enrollment of 110 is above the median of 79 across 47 interventional studies indexed under Jaundice.
Browse Jaundice studies →Quaid-e-Azam Medical College is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive oral zinc following neonatal dosing guidelines.
Drug: Zinc sulfate
Participants in this group will receive oral probiotics following neonatal dosing guidelines.
Drug: Probiotic lactobacillus rhamnosus GG
Oral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy.
Also known as: ZnSO4, Zinc
Oral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy.
Also known as: LGG, L. rhamnosus GG, Probiotic
Rate of decline in Bilirubin levels during phototherapy with this adjuvant therapy
Primary outcome measures the rate at which total serum bilirubin decreases in mg/dL per day in neonates undergoing phototherapy while receiving supplementation with either zinc or probiotics. Bilirubin levels will be recorded at baseline and at regular intervals until phototherapy is discontinued and hence rate of decline will be calculated.
Time frame: From initiation of supplementation with phototherapy to its completion (typically 3-7 days).
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Studies of the drugs tested here: Zinc Sulfate · Lacticaseibacillus rhamnosus GG
Quaid-e-Azam Medical College