Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Feeding and Eating Disorders of Childhood Clinical Trial

Official title:

Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060084
• Other study ID #: SYSD2012021
• 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

• Disease
• Disorder of Stomach Function and Feeding Problems in Newborn
• Feeding and Eating Disorders
• Feeding and Eating Disorders of Childhood
• Stomach Diseases

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