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NCT06449508 Clinical Trial

The Effectiveness of Probiotics in Neonatal Jaundice

Jaundice, Neonatal Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06449508
Other study ID # Probiotics in jaundice
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2024
Est. completion date July 1, 2025

Study information
Verified date June 2024
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 44
Est. completion date July 1, 2025
Est. primary completion date June 20, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Day to 30 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Probiotic Formula
drops of probiotic supplement containing bacillus clausil spores (Enterogermania Amp 2 Billion/5Ml )

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Outcome
Type Measure Description Time frame Safety issue
Primary the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin. up to 4 weeks
Secondary The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa) up to 4weeks
See also
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