Indirect HyperbilirubinemiaNCT07773012
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
A study testing Bifidobacterium animalis subsp. lactis and Standard Phototherapy in people with Indirect Hyperbilirubinemia, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
This study aims to evaluate the effectiveness of adjunctive oral Bifidobacterium animalis subsp. lactis in term neonates with indirect hyperbilirubinemia receiving phototherapy. The study will compare the effects of adjunctive probiotics plus standard phototherapy with standard phototherapy alone on the duration of… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Indirect Hyperbilirubinemia
- What is being tested?
- Bifidobacterium animalis subsp. lactis and Standard Phototherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2026to 31 May 2028
- Phase
- Interventional
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 0-28 days.
- Gestational age 37-42 weeks.
- Diagnosed with indirect hyperbilirubinemia according to the AAP 2022 guidelines.
- Eligible for phototherapy based on serum total bilirubin levels
- Informed consent obtained from a parent or legal guardian.
Who cannot join
- Direct hyperbilirubinemia (direct bilirubin >2.0 mg/dL and >20% of total serum bilirubin).
- Major congenital anomalies or severe concurrent illness (e.g., respiratory failure, intracranial hemorrhage).
- Indication for exchange transfusion, intravenous immunoglobulin (IVIG) or phenobarbital according to the AAP 2022 guidelines.
- Neonatal sepsis, blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, red blood cell membrane disorders.
- Suspected gastrointestinal obstruction.
- Unable to tolerate oral feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Duc Long Tran, PhD contact
Vietnam1 site
Can Tho University of Medicine and Pharmacy
Can Tho, 900000
Duc Long Tran, PhD, +842923739730, tdlong@ctump.edu.vn
About this study
Official title: Efficacy of Bifidobacterium Animalis Subsp. Lactis as an Adjunct to Phototherapy in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
This study aims to evaluate the effectiveness of adjunctive oral Bifidobacterium animalis subsp. lactis in term neonates with indirect hyperbilirubinemia receiving phototherapy. The study will compare the effects of adjunctive probiotics plus standard phototherapy with standard phototherapy alone on the duration of phototherapy, length of hospital stay, serum total bilirubin reduction, phototherapy-related adverse events, and hospital readmission after discharge.
Read the detailed description
Eligible term neonates with indirect hyperbilirubinemia requiring phototherapy will be randomly assigned to either the intervention group or the control group.
Neonates in the intervention group will receive oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day) in addition to standard phototherapy from the initiation of phototherapy until its discontinuation.
Neonates in the control group will receive standard phototherapy alone according to the hospital protocol.
All participants will undergo clinical evaluation and serum total bilirubin measurement before treatment and at day 3 of phototherapy. During hospitalization, the duration of phototherapy, length of hospital stay, serum bilirubin levels, and phototherapy-related adverse events will be recorded. Hospital readmission, including the occurrence, number, and primary reason for readmission, will be assessed at 28 days, 3 months, and 6 months of age.
- Conditions
- Indirect Hyperbilirubinemia
- Being tested
- Bifidobacterium animalis subsp. lactis, Standard Phototherapy
- Keywords
- Neonatal jaundice, Indirect hyperbilirubinemia, Phototherapy, Probiotics
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animalis subsp. lactisDrug
Standard phototherapy and oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day; 6 drops once daily)
Standard PhototherapyOther
Standard phototherapy without probiotic supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy and Probiotics | Experimental | Children will receive standard phototherapy in combination with oral Bifidobacterium animalis subsp. lactis throughout the phototherapy period. Receives: Drug: Bifidobacterium animalis subsp. lactis |
| Phototherapy | Active comparator | Children will only receive standard phototherapy without adjunctive probiotic supplementation. Receives: Other: Standard Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of phototherapy
The total duration of phototherapy, measured in hours
Measured: From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age
Change in serum total bilirubin level
The difference between serum total bilirubin levels measured before treatment initiation and at day 3 of treatment
Measured: At baseline and day 3 of treatment
Secondary outcomes (4)
Length of hospitalization
The total length of hospitalization, measured in days
Measured: From date of hospital admission until the date of hospital discharge, assessed up to 28 days of age
Adverse events
The occurrence of adverse events during treatment, including diarrhea, papular rash, dry skin with desquamation, hyperthermia, dehydration, and irritability
Measured: From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age
Rate of Hospital readmission
The proportion of participants who were readmitted to the hospital after discharge
Measured: At 28 days, 3 months, and 6 months of age
Number of Hospital readmissions
Total number of hospital readmissions per participant
Measured: At 28 days, 3 months, and 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion18 Aug 2026 (estimated)
- Study completion31 May 2028 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Thi Ngan Tam, Can Tho University of Medicine and Pharmacy
- Investigators
- Tam Thi Ngan Hua, MD, Principal investigator, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773012
- Sponsor's protocol ID
- 2855/QĐ-ĐHYDCT
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bifidobacterium Animalis Subsp. Lactis as an Adjunct to Phototherapy in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
- ClinicalTrials.gov ID
- NCT07773012
- Acronym / sponsor ID
- 2855/QĐ-ĐHYDCT
- Conditions
- Indirect Hyperbilirubinemia
- Keywords
- Neonatal jaundice, Indirect hyperbilirubinemia, Phototherapy, Probiotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 18 Aug 2026 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 19 Aug 2026 (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.
This study aims to evaluate the effectiveness of adjunctive oral Bifidobacterium animalis subsp. lactis in term neonates with indirect hyperbilirubinemia receiving phototherapy. The study will compare the effects of adjunctive probiotics plus standard phototherapy with standard phototherapy alone on the duration of phototherapy, length of hospital stay, serum total bilirubin reduction, phototherapy-related adverse events, and hospital readmission after discharge.
Detailed description
Eligible term neonates with indirect hyperbilirubinemia requiring phototherapy will be randomly assigned to either the intervention group or the control group.
Neonates in the intervention group will receive oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day) in addition to standard phototherapy from the initiation of phototherapy until its discontinuation.
Neonates in the control group will receive standard phototherapy alone according to the hospital protocol.
All participants will undergo clinical evaluation and serum total bilirubin measurement before treatment and at day 3 of phototherapy. During hospitalization, the duration of phototherapy, length of hospital stay, serum bilirubin levels, and phototherapy-related adverse events will be recorded. Hospital readmission, including the occurrence, number, and primary reason for readmission, will be assessed at 28 days, 3 months, and 6 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phototherapy and Probiotics | Experimental | Drug: Bifidobacterium animalis subsp. lactisChildren will receive standard phototherapy in combination with oral Bifidobacterium animalis subsp. lactis throughout the phototherapy period. |
| Phototherapy | Active comparator | Other: Standard PhototherapyChildren will only receive standard phototherapy without adjunctive probiotic supplementation. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age from 0-28 days.
- Gestational age 37-42 weeks.
- Diagnosed with indirect hyperbilirubinemia according to the AAP 2022 guidelines.
- Eligible for phototherapy based on serum total bilirubin levels
- Informed consent obtained from a parent or legal guardian.
Key exclusion criteria (6 listed)
- Direct hyperbilirubinemia (direct bilirubin >2.0 mg/dL and >20% of total serum bilirubin).
- Major congenital anomalies or severe concurrent illness (e.g., respiratory failure, intracranial hemorrhage).
- Indication for exchange transfusion, intravenous immunoglobulin (IVIG) or phenobarbital according to the AAP 2022 guidelines.
- Neonatal sepsis, blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, red blood cell membrane disorders.
- Suspected gastrointestinal obstruction.
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 |
|---|---|---|
| Bifidobacterium animalis subsp. lactisStandard phototherapy and oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day; 6 drops once daily) | Drug | Phototherapy and Probiotics |
| Standard PhototherapyStandard phototherapy without probiotic supplementation. | Other | Phototherapy |
Primary outcome
Duration of phototherapy
Time frame: From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age
The total duration of phototherapy, measured in hours
Change in serum total bilirubin level
Time frame: At baseline and day 3 of treatment
The difference between serum total bilirubin levels measured before treatment initiation and at day 3 of treatment
4 secondary outcomes
Length of hospitalization
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 28 days of age
Adverse events
Time frame: From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age
Rate of Hospital readmission
Time frame: At 28 days, 3 months, and 6 months of age
Number of Hospital readmissions
Time frame: At 28 days, 3 months, and 6 months of age
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 27 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
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
RecruitingPhase 2
COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
Indirect Hyperbilirubinemia, Neonatal
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.
Duc Long Tran, PhD contact
Tam Thi Ngan Hua, MD principal investigator
Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium animalis subsp. lactis and Standard Phototherapy in people with Indirect Hyperbilirubinemia, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Aug 2026. 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 Vietnam. 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.
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 Tam Thi Ngan Hua, MD (+84528073243, ngantam2001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of phototherapy (time frame: From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age). The study lists 2 primary outcomes in all. 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 27 Aug 2026.