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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03388112
Other study ID # SHSYEK2017
Secondary ID
Status Recruiting
Phase N/A
First received December 23, 2017
Last updated December 29, 2017
Start date February 20, 2017
Est. completion date December 31, 2018

Study information

Verified date December 2017
Source Shanghai 10th People's Hospital
Contact Yang Rong, MD
Phone 13321917107
Email leexuechun1@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This study aims to examin the impact of probiotics under 2 separate conditions, probiotics concurrent administration with antibiotic and probiotics administration during the recovery phase.Birth,7 days,14 days(or 21 days) and 42 days data will be collected and put into analysis to provide somes suggestions on the probiotics use in the clinical for the infants treated with antibiotics.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

- Newborns with infectious diseases treated with antibiotic

Exclusion Criteria:

- Gestational weeks <37

- Birth weight <2500g or =4000g

- History of asphyxia anoxia at birth

- With congenital metabolic diseases or hereditary diseases

- With gastrointestinal diseases

Study Design


Related Conditions & MeSH terms


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 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(or 21 days) on gut mcrobiome at 42 days change of the gut mcrobiome will be calculated at 42 days in comparison with birth,7 days,14 days(or 21 days) 42 days
Secondary change from birth on gut mcrobiome at 7 days change of the gut mcrobiome will be calculated at 7 days in comparison with baseline 7 days
Secondary change from birth and 7 days on gut mcrobiome at 14 days(or 21 days) change of the gut mcrobiome will be calculated at 14(or 21 days) in comparison with birth and 7 days 14 days(or 21days)
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