Effect of Probiotic Lacobacillus Reuterii on Serum Bilirubin Levels in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-10-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Probiotics on Neonatal Hyperbilirubinemia

NCT02807246

Neonatal Hyperbilirubinemia

COMPLETED NA

Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery

NCT04304014

Dysbiosis

COMPLETED NA

Prevention of the Minor Digestive Disorders by Lactobacillus Reuteri Supplementation

NCT01235884

Minor Digestive Disorders

COMPLETED NA

Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics

NCT02178267

Infant, Premature, Diseases

COMPLETED NA

Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants

NCT01531179

Necrotizing Enterocolitis Very Low Birth Weight Infants

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperbilirubinemia, Neonatal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The preterm infant subjects and their parents were blinded to whether they received the probiotic intervention or were in the control group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

Preterm infants who receive 5 drops of probiotic Lactobacillus reuteri for 7 days

Group Type EXPERIMENTAL

Lactobacillus reuterii

Intervention Type DIETARY_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

Control Group

Preterm infants who receive standard care without probiotics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus reuterii

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No