Clinical Trial: Probiotics in Infants With Gastroschisis

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Probiotics in Infants With Gastroschisis

Brief 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.

Detailed Summary: Infants with gastroschisis have decreased intestinal motility. This decrease in intestinal motility delays the introduction and advancement of feeds which prolongs hospitalization. The use of probiotic bacteria may improve intestinal motility. It is unknown whether the intestinal microbiota of infants with gastroschisis differs from that of healthy infants without gastroschisis and whether probiotics will change the microbiota. The primary outcome in this study is the composition of the fecal microbiota in infants with gastroschisis following surgical correction treated with Bifidobacterium infantis or placebo. We will also look at differences in hospital length of stay.
Sponsor: University of California, Davis

Current Primary Outcome: Composition of the fecal microbiota [ Time Frame: every two weeks for 6 weeks ]

Stools will be collected from messy diapers.


Original Primary Outcome: Same as current

Current Secondary Outcome: Length of hospital stay [ Time Frame: Initial discharge from the hospital ]

Number of days from surgery until discharge


Original Secondary Outcome: Same as current

Information By: University of California, Davis

Dates:
Date Received: March 14, 2011
Date Started: March 2011
Date Completion: September 2015
Last Updated: January 22, 2015
Last Verified: January 2015