Shanghai Infants Gut Microbiome Associated Study

Not Applicable

• Conditions: Gastrointestinal Microbiome
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT03388112
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-02-20
• Status Verified: 2017-12
• Study First Submitted: 2017-12-23
• Study First Submitted QC: 2017-12-29
• Last Update Submitted: 2017-12-29
• Primary Completion: 2017-12-31
• Study First Posted: 2018-01-02
• Last Update Posted: 2018-01-02
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotics after antibiotic	Probiotics	the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks after antibiotic.
probiotics concurrent with antibiotic	Probiotics	the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks concurrent with antibiotic.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, Shanghai, China