Shanghai Infants Gut Microbiome Associated Study
Effects of Probiotics on the Gut Microbiome of Infants Treated With Antibiotics
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants treated with antibiotics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2017
CompletedFirst Submitted
Initial submission to the registry
December 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedFirst Posted
Study publicly available on registry
January 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJanuary 2, 2018
December 1, 2017
10 months
December 23, 2017
December 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
change from birth on gut mcrobiome at 7 days
7 days
change from birth and 7 days on gut mcrobiome at 14 days(or 21 days)
14 days（or 21days）
Study Arms (3)
antibiotics
NO INTERVENTIONthe patients in this arm will not receive probiotics.
probiotics concurrent with antibiotic
EXPERIMENTALthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks concurrent with antibiotic.
probiotics after antibiotic
EXPERIMENTALthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks after antibiotic.
Interventions
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
Eligibility Criteria
You may qualify if:
- Newborns with infectious diseases treated with antibiotic
You may not qualify if:
- Gestational weeks \<37
- Birth weight \<2500g or ≥4000g
- History of asphyxia anoxia at birth
- With congenital metabolic diseases or hereditary diseases
- With gastrointestinal diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huanlong Qin
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 23, 2017
First Posted
January 2, 2018
Study Start
February 20, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2018
Last Updated
January 2, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share