Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Phase 4

Completed

• Conditions: Feeding and Eating Disorders of Childhood; Disorder of Stomach Function and Feeding Problems in Newborn
• Interventions: Drug: a control group; Drug: a probiotic-supplemented group

• Registration Number: NCT02060084
• Lead Sponsor: Wang Hua

Brief 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.

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 Timeline

• Status Verified: 2014-01
• Study Start: 2014-01
• Study First Submitted: 2014-02-02
• Study First Submitted QC: 2014-02-09
• Study First Posted: 2014-02-11
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2016-09-04
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a control group	a control group	a control group : the same dose of luke warm water
treatment group	a probiotic-supplemented group	treatment group: viable Bifidobacterium 0.5 bid po

Primary Outcome Measures

Name	Time	Method
Intestinal flora	up to one week	measure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants

Secondary Outcome Measures

Name	Time	Method
Feeding intolerance	up to one week	compare the feeding intolerance rate of three groups

Trial Locations

Locations (1)

Kunshan First Hospital; 🇨🇳 Kunshan, Jiangsu, China