Skip to main content
OpenTrials
Completed

NCT Number: NCT02060084

Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Disorder of Stomach Function and Feeding Problems in Newborn Feeding and Eating Disorders Feeding and Eating Disorders of Childhood Female Urogenital Diseases and Pregnancy Complications Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kunshan First Hospital

Kunshan, Jiangsu, 215300, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • preterm with birth weight <2.5kg

Exclusion criteria

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

Treatment and study plan

a control group

Drug

the same dose of luke warm water

a probiotic-supplemented group

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Feeding intolerance

    Time frame: up to one week

    compare the feeding intolerance rate of three groups

Sponsors and collaborators

Lead sponsor

Wang Hua

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.