The Effectiveness of Probiotics in Neonatal Jaundice

Phase 1

Not yet recruiting

• Conditions: Jaundice, Neonatal
• Interventions: Drug: Probiotic Formula

• Registration Number: NCT06449508
• Lead Sponsor: Tanta University

Brief Summary

Hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. Probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.

Detailed Description

Neonatal jaundice is a common health care issue that affects approximately 9% of newborns after birth. The percent of neonates who acquire jaundice in the first week of their birth is about 60%. while the percent of breasted neonates who develop jaundice during the first month of their birth is about 10%.

Phototherapy is the standard therapy for neonates who develop pathological jaundice, as it can alter bilirubin structure and increase its excretion.

Probiotics can also be used for the treatment of jaundice. The efficacy of probiotics depends on their ability to pass across the GIT and cause colonization in the intestinal lumen. Hence, it leads to a decrease in the bacterial growth in the small bowel, a reduction in the function of the gastrointestinal barrier, and a regulation of the immune system of the host.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-01
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-10
• Last Update Posted: 2024-06-10
• Study Start: 2024-07-01
• Primary Completion: 2025-06-20
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Neonate suffered from pathological unconjugated hyper-bilirubinemia with Total serum bilirubin (TSB) between 5-15mg/dl and need phototherapy.

Exclusion Criteria

• neonates who have kernicterus.
• neonates who have ventilation problem.
• neonates who have heart failure.
• -neonates who have asphyxia.
• neonates who have history of Rh incompatibility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotics	Probiotic Formula	will receive 5 drops of probiotic supplement containing Bacillus clausil spores (Enterogermania amp 2 billion/5 mL) once daily plus phototherapy till discharge.

Primary Outcome Measures

Name	Time	Method
the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa)	up to 4weeks