The Effectiveness of Probiotics in Neonatal Jaundice
ConditionJaundice, Neonatal
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-30
SponsorTanta University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonate suffered from pathological unconjugated hyper-bilirubinemia with Total serum bilirubin (TSB) between 5-15mg/dl and need phototherapy.
Disqualifiers
neonates who have kernicterus.
neonates who have ventilation problem.
neonates who have heart failure.
-neonates who have asphyxia.
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic Formula
Drugdrops of probiotic supplement containing bacillus clausil spores (Enterogermania Amp 2 Billion/5Ml )
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: controlNo intervention 0 interventions
Group B: probioticsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.
Time frame
up to 4 weeksSecondary outcomes
1
The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa)
Time frame
up to 4weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: