WithdrawnNot Applicable

A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants

Stopped: Pending further safety information regarding polysaccharides and premature infants

0Started 2011-06

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT01337921

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06-16

View on ClinicalTrials.gov More Feeding; Difficult, Newborn trials