Trial | NCT02060084  Report issue

Official Title

Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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 Started
Jan 31
2014
Primary Completion
Dec 31
2014
Study Completion
Dec 31
2014
Last Update
Sep 07
2016
Estimate

Drug a control group

the same dose of luke warm water

Drug 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

  • Other names: the experimental group

a control group Experimental

a control group : the same dose of luke warm water

treatment group Experimental

treatment group: viable Bifidobacterium 0.5 bid po

Criteria 

Inclusion Criteria:

preterm with birth weight <2.5kg

Exclusion Criteria:

Gastrointestinal bleeding and NEC,Kidney,liver function abnormal and have Serious congenital malformation
No Results Posted