A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
| Status: | Withdrawn |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/14/2017 |
| Start Date: | June 2011 |
| End Date: | June 2013 |
A Randomized Controlled Trial on a Multi-strain Synbiotic vs. a Multi-strain Probiotic on Fecal Colonization in the Very Low Birth Weight Infant
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.
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.
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.
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.
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
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Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
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