- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060084
Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preterm infants are at high risk of deeding intolerance especially low birth weight infants, Whether oral triple viable Bifidobacterium and early Micro-feeding may improve the symptoms of feeding intolerance.
84 preterm infants BW(birth weight) less than 2.5kg,entered neonatal intensive care unit(NICU) less than 24 hours and meet the Inclusion Criteria of this study will be Randomly divided into three groups, control group、 treatment group1 (Triple viable Bifidobacterium 0.5g bid po)、treatment group2 (Triple viable Bifidobacterium 0.5g bid po and early micro-feeding). treatment period for more than 1 week. For three groups, feeding symptoms,the traits and frequency of stool of 3 days,1 weeks,2 weeks.And the stool flora measured by PCR.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Kunshan, Jiangsu, China, 215300
- Kunshan First Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- preterm with birth weight <2.5kg
Exclusion Criteria:
- Gastrointestinal bleeding and NEC,Kidney,liver function abnormal and have Serious congenital malformation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: a control group
a control group : the same dose of luke warm water
|
the same dose of luke warm water
|
Experimental: treatment group
treatment group: viable Bifidobacterium 0.5 bid po
|
was orally administered starting from day 2 after birth, at a dose of 0.5g (the numbers of Long Bifidobacterium, Lactobacillus acidophilus and Enterococcus faecalis in live>0.5*107CFU),
twice per day, for 2 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intestinal flora
Time Frame: up to one week
|
measure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants
|
up to one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feeding intolerance
Time Frame: up to one week
|
compare the feeding intolerance rate of three groups
|
up to one week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSD2012021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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