Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

NCT ID: NCT02060084

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Disorder of Stomach Function and Feeding Problems in Newborn; Feeding and Eating Disorders of Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

a control group

a control group : the same dose of luke warm water

Group Type: EXPERIMENTAL

a control group

Intervention Type: DRUG

the same dose of luke warm water

treatment group

treatment group: viable Bifidobacterium 0.5 bid po

Group Type: EXPERIMENTAL

a probiotic-supplemented group

Intervention Type: 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

Interventions

a control group

the same dose of luke warm water

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

the experimental group

Eligibility Criteria

Inclusion Criteria

• preterm with birth weight <2.5kg

Exclusion Criteria

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

• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wang Hua

INDUSTRY

Sponsor Role: lead

Responsible Party

Wang Hua

Director of pediatric

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kunshan First Hospital

Kunshan, Jiangsu, China

Countries

China

Other Identifiers

SYSD2012021

Identifier Type: -

Identifier Source: org_study_id