Gastrointestinal Microbiome
Conditions
Keywords
Probiotics,Gut Microbiome,Antibiotics,Infants
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
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
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYang Rong, MD
Backup ContactHui Zhong, MD
Outcome results
None listed