search
Back to results

Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
a control group
a probiotic-supplemented group
Sponsored by
Wang Hua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Stomach Function and Feeding Problems in Newborn focused on measuring preterm;, Intestinal flora;, early Micro-feeding, Feeding intolerance

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • preterm with birth weight <2.5kg

Exclusion Criteria:

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

Sites / Locations

  • Kunshan First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

a control group

treatment group

Arm Description

a control group : the same dose of luke warm water

treatment group: viable Bifidobacterium 0.5 bid po

Outcomes

Primary Outcome Measures

Intestinal flora
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
compare the feeding intolerance rate of three groups

Full Information

First Posted
February 2, 2014
Last Updated
September 4, 2016
Sponsor
Wang Hua
search

1. Study Identification

Unique Protocol Identification Number
NCT02060084
Brief Title
Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm
Official Title
Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wang Hua

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Stomach Function and Feeding Problems in Newborn, Feeding and Eating Disorders of Childhood
Keywords
preterm;, Intestinal flora;, early Micro-feeding, Feeding intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a control group
Arm Type
Experimental
Arm Description
a control group : the same dose of luke warm water
Arm Title
treatment group
Arm Type
Experimental
Arm Description
treatment group: viable Bifidobacterium 0.5 bid po
Intervention Type
Drug
Intervention Name(s)
a control group
Intervention Description
the same dose of luke warm water
Intervention Type
Drug
Intervention Name(s)
a probiotic-supplemented group
Other Intervention Name(s)
the experimental group
Intervention Description
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
Primary Outcome Measure Information:
Title
Intestinal flora
Description
measure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants
Time Frame
up to one week
Secondary Outcome Measure Information:
Title
Feeding intolerance
Description
compare the feeding intolerance rate of three groups
Time Frame
up to one week

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kunshan First Hospital
City
Kunshan
State/Province
Jiangsu
ZIP/Postal Code
215300
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

We'll reach out to this number within 24 hrs