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

NCT01337921 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

  • Feeding; Difficult, Newborn
  • Necrotizing Enterocolitis

Interventions

DIETARY_SUPPLEMENT

Multi-strain Probiotic

Multi-strain Synbiotic: 1.5 billion CFU of Lactobacillus acidophilus, Bifidobacterium bifidum,and Bifidobacterium lactis WITH galacto-oligosaccharide(GOS)/fructo-oligosaccharide (FOS) combination at 1g/dL (0.9g/dL GOS/ 0.1g/dL FOS)

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Ann Anderson-Berry, MD · University of Nebraska

  • Corrine K Hanson, PhD · UNMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-06-16
Completion
2011-06-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337921 on ClinicalTrials.gov