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The Impact of Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Premature Infants

NCT00810160 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2017-07-13

No results posted yet for this study

Summary

The purpose of this study is to see whether dietary supplements can change the germs in the intestines of premature infants to be more like those of healthy breast fed term babies.

Conditions

  • Fecal Microflora in the Formula Fed Premature Infant

Interventions

DIETARY_SUPPLEMENT

ProlactPlus

Group 1 infants will be fed a concentration of Permeate mixed with formula. The ProlactPlus will be increased each week as follows: week 1 95:5 (formula:ProlactPlus), week 2 90:10, week 3 85:15, week 4 80:20, and week 5 75:25. Caloric content is roughly as follows: week 1 21 cal/oz, week 2 22 cal/oz, week 3 23 cal/oz, week 4 24 cal/oz, and week 5 25 cal/oz.

DIETARY_SUPPLEMENT

GOS galacto-oligosaccharides

Group 2 infants will have their formula supplemented with galacto-oligosaccharides (GOS) for each feeding as follows: week 1 0.25 g/dL, week 2 0.5 g/dL, week 3 1.0 g/dL, week 4 1.5 g/dL, and week 5 2.0 g/dL.

DIETARY_SUPPLEMENT

Bifidobacterium infantis

Group 3 infants will have their formula supplemented with B. infantis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.

DIETARY_SUPPLEMENT

Bifidobacterium animalis

Group 4 infants will have their formula supplemented with B. animalis twice daily increasing the dose each week as follows: week 1 5x107, week 2 1.5x108, week 3 4.5x108, week 4 1.4x109, and week 5 4.2x109.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Mark Underwood, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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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 NCT00810160 on ClinicalTrials.gov