Gut Microbiome Associated Study of Shanghai Infants With Jaundice

Gastrointestinal Microbiome Clinical Trial

Official title:

Effect of Probiotics on the Gut Mircobiome of Infants With Jaundice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03510936
• Other study ID #: SHSYEK2018
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2018
• Source: Shanghai 10th People's Hospital
• Contact: Rong Yang, MD
• Phone: 13321917107
• Email: leexuechun1[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Microbiome
• Jaundice

Intervention

Dietary Supplement:
• Probiotics
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

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change from birth on gut microbiome at 7 days by 16S rRNA	change of the gut microbiome will be calculated at 7 days in comparison with baseline	7 days
Secondary	change from birth and 7 days on gut microbiome at 14 days by 16S rRNA	change of the gut microbiome will be calculated at 14 days in comparison with birth and 7 days	14 days