Gut Microbiome Associated Study of Shanghai Infants With Jaundice
Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
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
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 18, 2018
CompletedFirst Posted
Study publicly available on registry
April 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 23, 2018
May 1, 2018
1.2 years
April 18, 2018
May 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA
change of the gut microbiome will be calculated at 42 days in comparison with birth,7 days,14 days
42 days
Secondary Outcomes (2)
change from birth on gut microbiome at 7 days by 16S rRNA
7 days
change from birth and 7 days on gut microbiome at 14 days by 16S rRNA
14 days
Study Arms (2)
blue light phototherapy
NO INTERVENTIONthe patients in this arm will not receive probiotics.
probiotics concurrent with phototherapy
EXPERIMENTALthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks
Interventions
the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis with does of 1.5\*10\^7CFU for 2 weeks
Eligibility Criteria
You may qualify if:
- Newborns with jaundice treated with blue light phototherapy
You may not qualify if:
- Gestational weeks \<37 Birth weight \<2500g or ≥4000g History of asphyxia anoxia at birth With infectious diseases treated with antibiotic With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai 10th People's Hospital
Shanghai, 20072, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huanlong Qin
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
April 18, 2018
First Posted
April 27, 2018
Study Start
January 1, 2018
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
May 23, 2018
Record last verified: 2018-05