Shanghai Infants Gut Microbiome Associated Study

Gastrointestinal Microbiome Clinical Trial

Official title:

Effects of Probiotics on the Gut Microbiome of Infants Treated With Antibiotics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03388112
• Other study ID #: SHSYEK2017
• 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
• 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

Related Conditions & MeSH terms

• Gastrointestinal Microbiome

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)