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Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wang Hua, Kunshan First People's Hospital Affiliated to Jiangsu University
ClinicalTrials.gov Identifier:
NCT02060084
First received: February 2, 2014
Last updated: September 4, 2016
Last verified: January 2014
  Purpose
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.

Condition Intervention Phase
Disorder of Stomach Function and Feeding Problems in Newborn
Feeding and Eating Disorders of Childhood
Drug: a control group
Drug: a probiotic-supplemented group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Further study details as provided by Kunshan First People's Hospital Affiliated to Jiangsu University:

Primary Outcome Measures:
  • Intestinal flora [ Time Frame: up to one week ] [ Designated as safety issue: No ]
    measure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants


Secondary Outcome Measures:
  • Feeding intolerance [ Time Frame: up to one week ] [ Designated as safety issue: No ]
    compare the feeding intolerance rate of three groups


Enrollment: 60
Study Start Date: January 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: a control group
a control group : the same dose of luke warm water
Drug: a control group
the same dose of luke warm water
Experimental: treatment group
treatment group: viable Bifidobacterium 0.5 bid po
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 Name: the experimental 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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm with birth weight <2.5kg

Exclusion Criteria:

  • Gastrointestinal bleeding and NEC,Kidney,liver function abnormal and have Serious congenital malformation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060084

Locations
China, Jiangsu
Kunshan First Hospital
Kunshan, Jiangsu, China, 215300
Sponsors and Collaborators
Wang Hua
  More Information

Responsible Party: Wang Hua, Director of pediatric, Kunshan First People's Hospital Affiliated to Jiangsu University
ClinicalTrials.gov Identifier: NCT02060084     History of Changes
Other Study ID Numbers: SYSD2012021 
Study First Received: February 2, 2014
Last Updated: September 4, 2016
Health Authority: China: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No
Plan Description: The patients were randomly assigned to either a control group or a probiotic-supplemented group in the following manner. The randomization schedule was made available only to the pharmacist who supervised the quality, transport and storage of LCB. Infants were followed up until they were discharged from the hospital or died. They were withdrawn from the trial if severe adverse effects developed, or parents withdrew consent. The probiotic-supplemented group were orally administered LCB (Bifico, Shanghai Xinyi Pharmaceutical Inc. Shanghai), and the control group was fed with the same dose of luke warm water); both the preparations were supplied in identical containers. LCB 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.

Keywords provided by Kunshan First People's Hospital Affiliated to Jiangsu University:
preterm;
Intestinal flora;
early Micro-feeding
Feeding intolerance

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Feeding and Eating Disorders of Childhood
Stomach Diseases
Pathologic Processes
Mental Disorders
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 29, 2016