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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02060084
Other study ID # SYSD2012021
Secondary ID
Status Completed
Phase Phase 4
First received February 2, 2014
Last updated September 4, 2016
Start date January 2014
Est. completion date December 2014

Study information

Verified date January 2014
Source Kunshan First People's Hospital Affiliated to Jiangsu University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Gut of newborn preterm is sterile, immediately by the mother and the surrounding environment from microbial colonization. As the effects of diet, intestinal flora is rapidly changed. Preterm children significantly delay in the establishment of normal flora,during hospitalization because of no breastfeeding, use of antibiotics, enteral feeding delay, combat disease and other factors. In this study, hospitalized preterm children for the study, the prospective randomized double-blind controlled study, to find oral intestinal bifidobacteria and lactobacilli and bifidobacteria subspecies composition and distribution, and further show intestinal bacteria in premature children case group.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 24 Hours
Eligibility Inclusion Criteria:

- preterm with birth weight <2.5kg

Exclusion Criteria:

- Gastrointestinal bleeding and NEC,Kidney,liver function abnormal and have Serious congenital malformation

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
a control group
the same dose of luke warm water
a probiotic-supplemented group
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

Locations

Country Name City State
China Kunshan First Hospital Kunshan Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Wang Hua

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intestinal flora measure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants up to one week No
Secondary Feeding intolerance compare the feeding intolerance rate of three groups up to one week No
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