Trials / Completed
CompletedNCT02060084
Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Wang Hua · Academic / Other
- Sex
- All
- Age
- 24 Hours
- Healthy volunteers
- Not accepted
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.
Conditions
- Disorder of Stomach Function and Feeding Problems in Newborn
- Feeding and Eating Disorders of Childhood
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | a control group | the same dose of luke warm water |
| 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 |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2014-02-11
- Last updated
- 2016-09-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02060084. Inclusion in this directory is not an endorsement.