An interventional study of Bifidobacterium animalis subsp. lactis and Standard Phototherapy in Indirect Hyperbilirubinemia, sponsored by Can Tho University of Medicine and Pharmacy. Not yet recruiting at 1 site in Vietnam. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
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.
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 90 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Children will receive standard phototherapy in combination with oral Bifidobacterium animalis subsp. lactis throughout the phototherapy period.
Drug: Bifidobacterium animalis subsp. lactis
Children will only receive standard phototherapy without adjunctive probiotic supplementation.
Other: Standard Phototherapy
Standard phototherapy and oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day; 6 drops once daily)
Standard phototherapy without probiotic supplementation.
Duration of phototherapy
The total duration of phototherapy, measured in hours
Time frame: 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
Time frame: At baseline and day 3 of treatment
Length of hospitalization
The total length of hospitalization, measured in days
Time frame: 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
Time frame: 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
Time frame: At 28 days, 3 months, and 6 months of age
Number of Hospital readmissions
Total number of hospital readmissions per participant
Time frame: At 28 days, 3 months, and 6 months of age
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bifidobacterium animalis subsp. lactis
Can Tho University of Medicine and Pharmacy