Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm

Wang Hua

Status and phase: Completed; Phase 4

Conditions: Disorder of Stomach Function and Feeding Problems in Newborn; Feeding and Eating Disorders of Childhood

Treatments: Drug: a control group; Drug: a probiotic-supplemented group

Study type: Interventional

Funder types: Industry

Identifiers

NCT02060084

SYSD2012021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

a control group

Experimental group

Description:

a control group : the same dose of luke warm water

Treatment:

Drug: a control group

treatment group

Experimental group

Description:

treatment group: viable Bifidobacterium 0.5 bid po

Treatment:

Drug: a probiotic-supplemented group