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Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02060084
Enrollment
60
Registered
2014-02-11
Start date
2014-01-31
Completion date
2014-12-31
Last updated
2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

preterm;, Intestinal flora;, early Micro-feeding, Feeding intolerance

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.

Interventions

DRUGa 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

DRUGa control group

the same dose of luke warm water

Sponsors

Wang Hua
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No

Inclusion criteria

* preterm with birth weight \<2.5kg

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Intestinal floraup to one weekmeasure the intestinal flora of three groups and identify the effect of early oral triple viable bifidobacterium for preterm infants

Secondary

MeasureTime frameDescription
Feeding intoleranceup to one weekcompare the feeding intolerance rate of three groups

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026