At a glance

ClinicalIndex Comparison Record

N/ACompleted· 90 enrolled

Drug / intervention

ProBioPlus +2 moredietary

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00282113

NCT00282113N/ACompleted

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Efficacy of a Prebiotic and Probiotic Combination in Preterm Infants

University of California, Davis·interventional·Posted Jan 25, 2006·Updated Jan 28, 2010

In Brief

A clinical study evaluating ProBioPlus, Culturelle, and 1 other intervention for Premature Infants and 2 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPremature Infants, Stool Bacterial Composition, Growth

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2004

First PostedJan 2006

Primary CompletionAug 2006

Study CompletionAug 2007

TodayJul 2026

First PostedJan 25, 2006

Enrollment StartOct 1, 2004

Primary CompletionAug 1, 2006

Study CompletionAug 1, 2007

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 20.4 years ago

Interventions

ProBioPlusdietary

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.

Culturelledietary

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

Placeboother

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