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Probiotics in Infants With Gastroschisis

NCT01316510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-07-13

Study results available
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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.

Conditions

  • Gastroschisis

Interventions

DIETARY_SUPPLEMENT

Bifidobacteria infantis

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

OTHER

Placebo

Dilute Nutramigen formula

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Mark A Underwood, MD · UC Davis

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-02-28
Completion
2015-08-31

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 NCT01316510 on ClinicalTrials.gov