Shanghai Infants Gut Microbiome Associated Study

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

Detailed Description
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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.

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

Conditions
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Gastrointestinal Microbiome

Intervention / Treatment
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* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: antibiotics<br>the patients in this arm will not receive probiotics. | |
| Experimental: probiotics concurrent with antibiotic<br>the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks concurrent with antibiotic. | Dietary Supplement: Probiotics<br>* 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<br>|
| Experimental: probiotics after antibiotic<br>the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks after antibiotic. | Dietary Supplement: Probiotics<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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） | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics,Gut Microbiome,Antibiotics,Infants