The Effectiveness of Probiotics in Neonatal Jaundice

Tanta University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Jaundice, Neonatal

Treatments: Drug: Probiotic Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT06449508

Probiotics in jaundice

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

control

No Intervention group

Description:

no intervention

probiotics

Active Comparator group

Description:

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

Treatment:

Drug: Probiotic Formula