The Efficacy of Oral Probiotics on Neonatal Hyperbilirubinemia
1 other identifier
interventional
180
1 country
1
Brief Summary
This trial will be carried out in two stages in the sick baby room of the Children's Hospital of China Medical University (CMUH). The first stage is: the enzyme active reaction kit (usually called API ZYM kit) was used to determine the β-glucuronidase activity of 9 strains of Lactobacillus and 4 strains of Bifidobacterium, screening out the probiotics that have the best inhibitory efficacy of intestinal β-glucuronidase activity; The second stage is: using the results of the first stage analysis, treating the newborns of jaundice by oral probiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedStudy Start
First participant enrolled
May 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 19, 2023
March 1, 2023
4.6 years
March 12, 2019
July 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum bilirubin level
The study will be conducted for 7 days, the serum bilirubin level will be measured every day.
7 days.
Secondary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events
7 days.
Study Arms (3)
Light therapy and oral L. salivarius AP-32
EXPERIMENTALLight therapy and taking 1 L. salivarius AP-32 probiotic capsule two times everyday for 7 days.
Light therapy and oral B. animalis subsp. lactis CP-9
EXPERIMENTALLight therapy and taking 1 B. animalis subsp. lactis CP-9 probiotic capsule two times everyday for 7 days.
Light therapy and oral placebo
PLACEBO COMPARATORLight therapy and taking 1 placebo capsule two times everyday for 7 days.
Interventions
Taking 1 probiotic capsule two times everyday for 7 days.
Taking 1 probiotic capsule two times everyday for 7 days.
Eligibility Criteria
You may qualify if:
- Full-term infants (≧37 weeks).
- Jaundice index greater than 15 mg/dl on the fourth day after birth.
You may not qualify if:
- Hypothyroidism
- Trisomy 21
- Maternal blood type A, B and O incompatibility
- Gastrointestinal disease
- Glucose-6-Phosphate Dehydrogenase deficiency (G6PD deficiency)
- Hemangioma
- Cephalhaematoma or hemorrhages
- Severe asphyxia (stage III)
- Fetal chromosomal anomalies
- Cyanotic congenital heart disease
- Omphalocele
- Early onset sepsis
- Liver failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 40447, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hung-chih Lin
China Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 15, 2019
Study Start
May 24, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 19, 2023
Record last verified: 2023-03