Hyperbilirubinemia, NeonatalNCT06672406
Effect of Probiotic Lacobacillus Reuterii on Serum Bilirubin Levels in Preterm Infants
A study testing Lactobacillus reuterii in people with Hyperbilirubinemia, Neonatal, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn about the effect of probiotic Lactobacillus reuterii on the level of serum bilirubin in moderately and late preterm infants with birth weights 1000 grams to 2499 grams who were admitted to the NICU at Dr. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Lactobacillus reuterii
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature Infants (32 - < 37 weeks gestation)
- Birth weight 1000 - 2499 grams
- Sick infants who are treated in the NICU
- Preterm infants who received enteral feeding > 30 cc/kgBB less than 72 hours after birth, without jaundice or jaundice Kremer 1,2, and 3
- Parents have signed their child's consent to participate in the study
Who cannot join
- Infants with multiple congenital abnormalities
- Infants with jaundice before 24 hours or having jaundice cremer > 4 less than 72 hours from birth
- Infants with Sepsis, Metabolic acidosis
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn about the effect of probiotic Lactobacillus reuterii on the level of serum bilirubin in moderately and late preterm infants with birth weights 1000 grams to 2499 grams who were admitted to the NICU at Dr. Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital and Cahaya Medika Hospital. The main questions it aims to answer are:
- Are bilirubin levels in preterm infants who received probiotics were lower than those who did not receive probiotics?
- Is the incidence of hyperbilirubinemia requiring phototherapy in preterm infants who received probiotics less than those who did not receive probiotics?
Read the detailed description
This study aims to investigate the effect of probiotic Lactobacillus reuteri administration on serum bilirubin levels in preterm infants. It is a randomized controlled trial conducted at the Neonatal Intensive Care Units of Dr. Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital and Cahaya Medika Hospital in Makassar, South Sulawesi, Indonesia. The study population includes infants born at 32 to <37 weeks gestational age with birth weights between 1000-2499 grams who are admitted to the NICU. Eligible infants are randomized into two groups - an intervention group receiving probiotic L. reuteri (5 drops daily for 7 days) and a control group not receiving probiotics. The primary outcome is serum bilirubin levels, measured at baseline and after 7 days of intervention. Secondary outcomes include incidence of hyperbilirubinemia requiring phototherapy and changes in bilirubin levels in those receiving phototherapy. Blood samples are collected to measure total and direct bilirubin levels. The study aims to enroll 40 infants (20 per group) to detect a clinically meaningful difference in bilirubin levels between groups. This trial will provide evidence on whether probiotic supplementation with L. reuteri can reduce the severity of hyperbilirubinemia in preterm infants. The results may inform clinical practice regarding the use of probiotics as an adjunctive therapy for neonatal jaundice in this vulnerable population.
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Lactobacillus reuterii
- Keywords
- hyperbilirubinemia, probiotic, Lactobacillus reuterii
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriiDietary supplement
Participants in the intervention group received probiotic Lactobacillus reuterii if they received enteral feeding > 30 cc/kgBW. 5 drops of probiotics were given for 7 days in the breast milk or formula milk that did not contain probiotics
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Preterm infants who receive 5 drops of probiotic Lactobacillus reuteri for 7 days Receives: Dietary Supplement: Lactobacillus reuterii |
| Control Group | No intervention | Preterm infants who receive standard care without probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total bilirubin level
We compare the total bilirubin level between participants who received probiotics and those who did not receive probiotics
Measured: Total bilirubin level was measured after 7th day of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Jan 2024
- Primary completion21 Sep 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperbilirubinemia, NeonatalStudies 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
- Model description
- This randomized controlled trial aims to assess the effect of probiotic Lactobacillus reuteri on serum bilirubin levels in preterm infants. The study will be conducted at NICUs in Makassar, Indonesia, enrolling infants born at 32 to \<37 weeks gestation with birth weights of 1000-2499 grams. Forty infants will be randomized to receive either L. reuteri probiotic (5 drops daily for 7 days) or no probiotic. The primary outcome is serum bilirubin levels measured at baseline and after 7 days. Secondary outcomes include incidence of hyperbilirubinemia requiring phototherapy and changes in bilirubin levels in those receiving phototherapy. Blood samples will be collected to measure total and direct bilirubin. This trial will provide evidence on whether L. reuteri supplementation can reduce hyperbilirubinemia severity in preterm infants, potentially informing clinical practice regarding probiotic use as an adjunctive therapy for neonatal jaundice in this vulnerable population.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurwahyuni Rachim, Hasanuddin University
- Investigators
- Nurwahyuni Rachim, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672406
- Sponsor's protocol ID
- UH105201003
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med. 2014 May 21;6(237):237ra65. doi: 10.1126/scitranslmed.3008599.
PubMed 24848255
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Lacobacillus Reuterii on Serum Bilirubin Levels in Preterm Infants
- ClinicalTrials.gov ID
- NCT06672406
- Acronym / sponsor ID
- UH105201003
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- hyperbilirubinemia, probiotic, Lactobacillus reuterii
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 21 Sep 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 4 Nov 2024 (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.
The goal of this clinical trial is to learn about the effect of probiotic Lactobacillus reuterii on the level of serum bilirubin in moderately and late preterm infants with birth weights 1000 grams to 2499 grams who were admitted to the NICU at Dr. Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital and Cahaya Medika Hospital. The main questions it aims to answer are:
- Are bilirubin levels in preterm infants who received probiotics were lower than those who did not receive probiotics?
- Is the incidence of hyperbilirubinemia requiring phototherapy in preterm infants who received probiotics less than those who did not receive probiotics?
Detailed description
This study aims to investigate the effect of probiotic Lactobacillus reuteri administration on serum bilirubin levels in preterm infants. It is a randomized controlled trial conducted at the Neonatal Intensive Care Units of Dr. Wahidin Sudirohusodo Hospital, Hasanuddin University Hospital and Cahaya Medika Hospital in Makassar, South Sulawesi, Indonesia. The study population includes infants born at 32 to <37 weeks gestational age with birth weights between 1000-2499 grams who are admitted to the NICU. Eligible infants are randomized into two groups - an intervention group receiving probiotic L. reuteri (5 drops daily for 7 days) and a control group not receiving probiotics. The primary outcome is serum bilirubin levels, measured at baseline and after 7 days of intervention. Secondary outcomes include incidence of hyperbilirubinemia requiring phototherapy and changes in bilirubin levels in those receiving phototherapy. Blood samples are collected to measure total and direct bilirubin levels. The study aims to enroll 40 infants (20 per group) to detect a clinically meaningful difference in bilirubin levels between groups. This trial will provide evidence on whether probiotic supplementation with L. reuteri can reduce the severity of hyperbilirubinemia in preterm infants. The results may inform clinical practice regarding the use of probiotics as an adjunctive therapy for neonatal jaundice in this vulnerable population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This randomized controlled trial aims to assess the effect of probiotic Lactobacillus reuteri on serum bilirubin levels in preterm infants. The study will be conducted at NICUs in Makassar, Indonesia, enrolling infants born at 32 to <37 weeks gestation with birth weights of 1000-2499 grams. Forty infants will be randomized to receive either L. reuteri probiotic (5 drops daily for 7 days) or no probiotic. The primary outcome is serum bilirubin levels measured at baseline and after 7 days. Secondary outcomes include incidence of hyperbilirubinemia requiring phototherapy and changes in bilirubin levels in those receiving phototherapy. Blood samples will be collected to measure total and direct bilirubin. This trial will provide evidence on whether L. reuteri supplementation can reduce hyperbilirubinemia severity in preterm infants, potentially informing clinical practice regarding probiotic use as an adjunctive therapy for neonatal jaundice in this vulnerable population.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Lactobacillus reuteriiPreterm infants who receive 5 drops of probiotic Lactobacillus reuteri for 7 days |
| Control Group | No intervention | –Preterm infants who receive standard care without probiotics |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Premature Infants (32 - < 37 weeks gestation)
- Birth weight 1000 - 2499 grams
- Sick infants who are treated in the NICU
- Preterm infants who received enteral feeding > 30 cc/kgBB less than 72 hours after birth, without jaundice or jaundice Kremer 1,2, and 3
- Parents have signed their child's consent to participate in the study
Key exclusion criteria (3 listed)
- Infants with multiple congenital abnormalities
- Infants with jaundice before 24 hours or having jaundice cremer > 4 less than 72 hours from birth
- Infants with Sepsis, Metabolic acidosis
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 |
|---|---|---|
| Lactobacillus reuteriiParticipants in the intervention group received probiotic Lactobacillus reuterii if they received enteral feeding > 30 cc/kgBW. 5 drops of probiotics were given for 7 days in the breast milk or formula milk that did not contain probiotics | Dietary supplement | Intervention Group |
Primary outcome
Total bilirubin level
Time frame: Total bilirubin level was measured after 7th day of intervention
We compare the total bilirubin level between participants who received probiotics and those who did not receive probiotics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 24848255Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med. 2014 May 21;6(237):237ra65. doi: 10.1126/scitranslmed.3008599.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nurwahyuni Rachim, MD principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuterii in people with Hyperbilirubinemia, Neonatal, run by Hasanuddin University at 1 site in Indonesia.
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 3 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: finished, as of the sponsor's last update on 26 Nov 2024. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total bilirubin level (time frame: Total bilirubin level was measured after 7th day of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06672406, which also lists 1 linked publication.
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 26 Nov 2024.