NCT02060084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 7, 2016

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

February 2, 2014

Last Update Submit

September 4, 2016

Conditions

Disorder of Stomach Function and Feeding Problems in NewbornFeeding and Eating Disorders of Childhood

Keywords

preterm;Intestinal flora;early Micro-feedingFeeding intolerance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Feeding intolerance

    up to one week

Study Arms (2)

a control group

EXPERIMENTAL

a control group : the same dose of luke warm water

Drug: a control group

treatment group

EXPERIMENTAL

treatment group: viable Bifidobacterium 0.5 bid po

Drug: a probiotic-supplemented group

Interventions

a control groupDRUG

the same dose of luke warm water

a control group
a probiotic-supplemented groupDRUG

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

Also known as: the experimental group
treatment group

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm with birth weight \<2.5kg

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kunshan First Hospital

Kunshan, Jiangsu, 215300, China

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of ChildhoodPremature Birth

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of pediatric

Study Record Dates

First Submitted

February 2, 2014

First Posted

February 11, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 7, 2016

Record last verified: 2014-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

CN(1)