Shanghai Infants Gut Microbiome Associated Study

Tongji University

Status: Unknown

Conditions: Gastrointestinal Microbiome

Treatments: Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03388112

SHSYEK2017

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

antibiotics

No Intervention group

Description:

the patients in this arm will not receive probiotics.

probiotics concurrent with antibiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotics

probiotics after antibiotic

Experimental group

Description:

the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks after antibiotic.

Treatment:

Dietary Supplement: Probiotics