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

NCT07102836 | Recruiting Phase 2 DMC

• 2 other identifiers: QAMC-CT-01248/DME/QAMC Bahawalpur
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Indirect Hyperbilirubinemia; Neonatal

Keywords

Zinc; Probiotics; Jaundice; Phototherapy; Neonates; Randomized Controlled Trial; Bilirubin; Enterohepatic Circulation; Indirect Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Zinc group

EXPERIMENTAL

Participants in this group will receive oral zinc following neonatal dosing guidelines.

Drug: Zinc sulfate

Probiotics group

EXPERIMENTAL

Participants in this group will receive oral probiotics following neonatal dosing guidelines.

Drug: Probiotic lactobacillus rhamnosus GG

Interventions

Zinc sulfate DRUG

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

Also known as: ZnSO4, Zinc

Zinc group

Probiotic lactobacillus rhamnosus GG DRUG

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

Also known as: LGG, L. rhamnosus GG, Probiotic

Probiotics group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Quaid-e-Azam Medical College: lead

Study Sites (1)

Sadiq Abbasi Hospital, QAMC, Bahawalpur

Bahawalpur, Punjab Province, 63100, Pakistan

RECRUITING

MeSH Terms

Conditions

Jaundice

Interventions

Zinc Sulfate; Zinc; Probiotics

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Malik M. Umair Fazal, MBBS, FCPS Paediatrics

  Quaid-e-Azam Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malik M. Umair Fazal, MBBS, FCPS Paediatrics

CONTACT

+923318682681; umair.malik1622@gmail.com

Dr. Muhammad Anwar, MBBS, FCPS Neonatology

CONTACT

+923216820943; hmanwar157@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both participants and care provider will be blinded to intervention allocation. Preparation of both drugs will be made identical in appearance and packaging to ensure unbiased administration and assessment during phototherapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Malik Muhammad Umair Fazal

Model Details: Participants will be randomly assigned to two groups. One group will receive Zinc and other will be receiving Probiotics. This will be done in continuation of Phototherapy to compare the effects of both drugs in reducing indirect hyperbilirubinemia.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 5, 2025
• Study Start: August 7, 2025
• Primary Completion: February 7, 2026
• Study Completion: May 7, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

PA (1)