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Effects of Probiotic and Prebiotic Combinations on Premature Infants

NCT00282113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-01-28

Study results available
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Summary

The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants. Our hypothesis is that short term growth will be improved, the stool will have more healthy bacteria, and the fecal short chain fatty acid content will increase in the babies who receive the probiotic/prebiotic combinations compared to control groups.

Conditions

  • Premature Infants
  • Stool Bacterial Composition
  • Growth

Interventions

DIETARY_SUPPLEMENT

ProBioPlus

ProBioPlus is advertised as containing Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium infantis, and Bifidobacterium bifidum plus inulin. The dose given was 5 x 10e8 twice daily.

DIETARY_SUPPLEMENT

Culturelle

Culturelle is advertised as containing Lactobacillus rhamnosus GG. The dose was 5 x 10e8 twice daily.

OTHER

Placebo

A dilute preparation of pregestimil powder formulated to have a similar appearance to the probiotic products

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Michael P Sherman, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2006-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00282113 on ClinicalTrials.gov