Indirect HyperbilirubinemiaPhase 2ZIPPNCT07102836
COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
A Phase 2 study testing Zinc sulfate and Probiotic lactobacillus rhamnosus GG in people with Indirect Hyperbilirubinemia and Neonatal, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Indirect Hyperbilirubinemia, Neonatal
- What is being tested?
- Zinc sulfate and Probiotic lactobacillus rhamnosus GG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Aug 2025to 7 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malik M. Umair Fazal, MBBS, FCPS Paediatrics contact
Dr. Muhammad Anwar, MBBS, FCPS Neonatology contact
Pakistan1 site, 1 recruiting
- Recruiting
Sadiq Abbasi Hospital, QAMC, Bahawalpur
Bahawalpur, Punjab Province, 63100
About this study
Official title: COMPARATIVE EFFECTS OF ZINC AND PROBIOTICS ON NEONATAL 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.
- Conditions
- Indirect Hyperbilirubinemia, Neonatal
- Being tested
- Zinc sulfate, Probiotic lactobacillus rhamnosus GG
- Keywords
- Zinc, Probiotics, Jaundice, Phototherapy, Neonates, Randomized Controlled Trial, Bilirubin, Enterohepatic Circulation, Indirect Hyperbilirubinemia
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc sulfateDrug
Also called ZnSO4, Zinc
Oral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy.
Probiotic lactobacillus rhamnosus GGDrug
Also called LGG, L. rhamnosus GG, Probiotic
Oral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy.
| Study group | Role | What they receive |
|---|---|---|
| Zinc group | Experimental | Participants in this group will receive oral zinc following neonatal dosing guidelines. Receives: Drug: Zinc sulfate |
| Probiotics group | Experimental | Participants in this group will receive oral probiotics following neonatal dosing guidelines. Receives: Drug: Probiotic lactobacillus rhamnosus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initiation of supplementation with phototherapy to its completion (typically 3-7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start7 Aug 2025 (estimated)
- Primary completion7 Feb 2026 (estimated)
- Study completion7 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quaid-e-Azam Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malik Muhammad Umair Fazal, Quaid-e-Azam Medical College
- Investigators
- Malik M. Umair Fazal, MBBS, FCPS Paediatrics, Principal investigator, Quaid-e-Azam Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102836
- Sponsor's protocol ID
- QAMC-CT-01
- Other IDs
- 248/DME/QAMC Bahawalpur
- Acronym
- ZIPP
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EFFECTS OF ZINC AND PROBIOTICS ON NEONATAL INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
- ClinicalTrials.gov ID
- NCT07102836
- Acronym / sponsor ID
- ZIPP / QAMC-CT-01
- Conditions
- Indirect Hyperbilirubinemia, Neonatal
- Keywords
- Zinc, Probiotics, Jaundice, Phototherapy, Neonates, Randomized Controlled Trial, Bilirubin, Enterohepatic Circulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Quaid-e-Azam Medical CollegeUniversity, hospital or other
- Study start
- 7 Aug 2025 (estimated)
- Primary completion
- 7 Feb 2026 (estimated)
- Study completion
- 7 May 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Zinc group | Experimental | Drug: Zinc sulfateParticipants in this group will receive oral zinc following neonatal dosing guidelines. |
| Probiotics group | Experimental | Drug: Probiotic lactobacillus rhamnosus GGParticipants in this group will receive oral probiotics following neonatal dosing guidelines. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc sulfateAlso: ZnSO4, ZincOral zinc sulfate syrup in a dose providing 5mg elemental zinc daily as adjuvant to phototherapy. | Drug | Zinc group |
| Probiotic lactobacillus rhamnosus GGAlso: LGG, L. rhamnosus GG, ProbioticOral Probiotic Lactobacillus rhamnosus GG drops daily as adjuvant to phototherapy. | Drug | Probiotics group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Related trials for Indirect Hyperbilirubinemia
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Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
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Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Recruiting
The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia
Hyperbilirubinemia, Neonatal Indirect
Not yet recruiting
Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice
Newborn Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malik M. Umair Fazal, MBBS, FCPS Paediatrics contact
Dr. Muhammad Anwar, MBBS, FCPS Neonatology contact
Malik M. Umair Fazal, MBBS, FCPS Paediatrics principal investigator
Quaid-e-Azam Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc sulfate and Probiotic lactobacillus rhamnosus GG in people with Indirect Hyperbilirubinemia and Neonatal, run by Quaid-e-Azam Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malik M. Umair Fazal, MBBS, FCPS Paediatrics (+923318682681 ext. +92622720235, umair.malik1622@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.