N/A N=90 Randomized Triple-blind Prevention

Effects of Probiotic and Prebiotic Combinations on Premature Infants

Premature Infants · Stool Bacterial Composition · Growth

Bottom Line

View on ClinicalTrials.gov: NCT00282113 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2010

Primary outcome: Primary: Weight Gain — 618; 590; 682 Grams — p=>0.5

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ProBioPlus (Dietary_supplement); Culturelle (Dietary_supplement); Placebo (Other)
Age: Pediatric
Sex: All
Sponsor: University of California, Davis
Primary completion: Aug 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Gain	618; 590; 682	>0.5
SECONDARY Stool Colonization With Bifidobacteria	7; 2; 3	0.06
SECONDARY Stool Short Chain Butyric Acid Content	5.1; 8.3; 7.7	>0.05

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.

Eligibility Criteria

Inclusion Criteria

less than 35 weeks gestation, birth weight 750-2000 grams
born in or transferred to University of California Davis Medical Center within first week of life
less than eight days of age at the time of enrollment

Exclusion Criteria

Severe intestinal or cardiac congenital anomalies

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Data sourced from ClinicalTrials.gov (NCT00282113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.