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The Effectiveness of Probiotics in Neonatal Jaundice

Role of Probiotics Administered as an Adjuvant Therapy in Pathological Neonatal Unconjugated Hyperbilirubinemia

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06449508
Enrollment
44
Registered
2024-06-10
Start date
2024-07-01
Completion date
2025-07-01
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Neonatal

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.

Interventions

drops of probiotic supplement containing bacillus clausil spores (Enterogermania Amp 2 Billion/5Ml )

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.up to 4 weeks

Secondary

MeasureTime frame
The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa)up to 4weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026