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NCT Number: NCT07102836

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

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.

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Key information

Conditions

Indirect Hyperbilirubinemia Hyperbilirubinemia Jaundice Neonatal Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sadiq Abbasi Hospital, QAMC, Bahawalpur

Bahawalpur, Punjab Province, 63100, Pakistan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Term or Near term neonates 2. Age <7 days at enrollment 3. Bilirubin levels within phototherapy range according to NICE bilirubin threshold charts 4. No identifiable pathology 5. Tolerating oral feeds 6. Parental or Guardian written informed consent taken.

Exclusion criteria

  • 1. Positive sepsis screen or clinical signs of infection 2. Direct hyperbilirubinemia 3. Gastrointestinal malformations 4. Oral intolerance 5. Requiring mechanical ventilation 6. Congenital anomalies 7. Parental or Guardian refusal to participate in study

Treatment and study plan

zinc sulfate

Drug

Oral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy.

Other names: ZnSO4, Zinc

Probiotic lactobacillus rhamnosus GG

Drug

Oral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy.

Other names: LGG, L. rhamnosus GG, Probiotic

Primary outcomes

  1. Rate of decline in Bilirubin levels during phototherapy with this adjuvant therapy

    Time frame: From initiation of supplementation with phototherapy to its completion (typically 3-7 days).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Muhammad Anwar, MBBS, FCPS Neonatology

CONTACT

[email protected]

+923216820943 ext. +92622720235

Malik M. Umair Fazal, MBBS, FCPS Paediatrics

CONTACT

[email protected]

+923318682681 ext. +92622720235

Sponsors and collaborators

Lead sponsor

Quaid-e-Azam Medical College

Other

Registry information

Official study title

COMPARATIVE EFFECTS OF ZINC AND PROBIOTICS ON NEONATAL INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY

Acronym: ZIPP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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