CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Bifidobacteria infantis +1 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/NCT01316510
NCT01316510N/ACompleted
CompareCT.gov

Probiotics in Infants With Gastroschisis

University of California, Davis·interventional·Posted Mar 16, 2011·Updated Jul 13, 2018

In Brief

A clinical study evaluating Bifidobacteria infantis and Placebo for Gastroschisis. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Infants born with gastroschisis usually require surgery shortly after birth. After surgery the intestine is often unable to digest human milk or formula for weeks or months. During this time the baby has to remain in the hospital to receive special nutrition through an IV. How bacteria colonize the intestine in these babies is unknown. Probiotics are bacteria that appear to have beneficial effects on digestion. This study will test whether giving probiotic bacteria to babies after surgery for gastroschisis will change the bacteria in the intestine to be more like those of a healthy breast-fed baby.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroschisis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2011
Enrollment StartMar 1, 2011
Primary CompletionFeb 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 15.3 years ago

Interventions

Bifidobacteria infantisdietary

1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge

Placeboother

Dilute Nutramigen formula