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

NCT06672406 | Completed

• 1 other identifier: UH105201003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Hyperbilirubinemia, Neonatal

Keywords

hyperbilirubinemia; probiotic; Lactobacillus reuterii

Outcome Measures

Primary Outcomes (1)

• Total bilirubin level

  We compare the total bilirubin level between participants who received probiotics and those who did not receive probiotics

  Total bilirubin level was measured after 7th day of intervention

Other Outcomes (1)

• Phototherapy

  The need for phototherapy was assessed throughout the intervention (7 days)

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus reuterii

Control Group

NO INTERVENTION

Preterm infants who receive standard care without probiotics

Interventions

Lactobacillus reuterii 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

Intervention Group

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 24848255 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nurwahyuni Rachim, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The preterm infant subjects and their parents were blinded to whether they received the probiotic intervention or were in the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Nurwahyuni Rachim

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 4, 2024
• Study Start: January 1, 2024
• Primary Completion: September 21, 2024
• Study Completion: October 21, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)