Clinical trial NCT01337921: A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
Official title: A Randomized Controlled Trial on a Multi-strain Synbiotic vs. a Multi-strain Probiotic on Fecal Colonization in the Very Low Birth Weight Infant
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Feeding; Difficult, Newborn
Necrotizing Enterocolitis
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34 weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1, DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24 months CGA.

Detailed description: Feeding Intolerance and other GI issues are a major concern in a NICU hospitalized population. Successful colonization with probiotic bacteria is thought to impact the incidence of GI related issues. This study will study the impact of prebiotics on the colonization of a population of VLBW infants in the NICU setting.

Eligibility criteria: Inclusion Criteria:

* infants with a birth weight \< 1500g
* admission to NICU at The Nebraska Medical Center

Exclusion Criteria:

* infants who have congenital anomalies
* have a diagnosis of a congenital metabolic disease
* are made a ward of the State or
* are born to a mother \< 19 years of age

Primary outcomes:
measure: Comparing a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts
timeFrame: 1,2, 3, 4 and 34 weeks of age
Secondary outcomes:
measure: Compare the difference between two groups (multi-strain synbiotic vs. multi-strain probiotic) on demographic data and selected standard clinical infant outcomes.
timeFrame: From birth to NICU discharge (average 36 weeks corrected gestational age)
measure: Compare the difference between infants successfully colonized with probiotic organisms (>10^2 colonies on a 10^4-fold dilution plate)to infants not successfully colonized on demographics and selected standard clinical outcomes
timeFrame: 1 week of life to NICU discharge
measure: Compare infants successfully colonized with probiotic organisms(>10^2 colonies on a 10^4-fold dilution plate) to infants not successfully colonized on stress biomarker levels
timeFrame: day of life 1 to day of life 7
measure: Compare trends of stress biomarker levels in relation to demographics and selected standard infant outcomes
timeFrame: day of life 1 to day of life 7
measure: Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes.
timeFrame: 6, 16 & 24 months corrected gestational age.
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Ann Anderson-Berry, MD
role: STUDY_CHAIR
affiliation: UNMC
name: Corrine K Hanson, PhD
role: STUDY_CHAIR
References: