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Gut Microbiome Associated Study of Shanghai Infants With Jaundice

Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03510936
Enrollment
30
Registered
2018-04-27
Start date
2018-01-01
Completion date
2019-03-01
Last updated
2018-05-23

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

Conditions

Gastrointestinal Microbiome

Keywords

Probiotics, Gut Microbiome, Infants, Jaundice

Brief summary

The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.

Detailed description

This study aims to examin the impact of probiotics administration during the process of infants jaundice treatment and recovery phase.the recovery phase.Birth,7 days,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants with jaundice.

Interventions

DIETARY_SUPPLEMENTProbiotics

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

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No

Inclusion criteria

* Newborns with jaundice treated with blue light phototherapy

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
change from birth,7 days,14 days on gut microbiome at 42 days by 16S rRNA42 dayschange of the gut microbiome will be calculated at 42 days in comparison with birth,7 days,14 days

Secondary

MeasureTime frameDescription
change from birth on gut microbiome at 7 days by 16S rRNA7 dayschange of the gut microbiome will be calculated at 7 days in comparison with baseline
change from birth and 7 days on gut microbiome at 14 days by 16S rRNA14 dayschange of the gut microbiome will be calculated at 14 days in comparison with birth and 7 days

Countries

China

Contacts

Primary ContactRong Yang, MD
leexuechun1@126.com13321917107
Backup ContactHui Zhong
zhonghuiunique@126.com13701806709

Outcome results

None listed

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