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Could a probiotic speed up newborn jaundice recovery?

NCT ID NCT07773012

Disease control Sponsor: Can Tho University of Medicine and Pharmacy Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This trial tests whether giving a probiotic (Bifidobacterium animalis subsp. lactis) alongside standard phototherapy helps full-term newborns with jaundice recover faster. The study compares the duration of light therapy, hospital stay, and bilirubin levels between infants receiving the probiotic plus phototherapy and those receiving phototherapy alone. It aims to see if the probiotic reduces treatment time and complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bifidobacterium animalis subsp. lactis, a probiotic given orally as drops alongside standard phototherapy
What this could lead to
If effective, adding this probiotic to standard light therapy could shorten hospital stays and reduce jaundice-related complications in newborns.
What could go wrong
This is a small, early-stage trial, and the probiotic may not significantly improve outcomes. Potential side effects like diarrhea or rash are also possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

hyperbilirubinemia Jaundice, Neonatal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Indirect hyperbilirubinemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Can Tho University of Medicine and Pharmacy

    Can Tho, 900000, Vietnam

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