Probiotics in Infants With Gastroschisis
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||Probiotics in Infants With Gastroschisis|
- Composition of the fecal microbiota [ Time Frame: every two weeks for 6 weeks ] [ Designated as safety issue: No ]Stools will be collected from messy diapers.
- Length of hospital stay [ Time Frame: Initial discharge from the hospital ] [ Designated as safety issue: No ]Number of days from surgery until discharge
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Bifidobacteria infantis
1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)
Dietary Supplement: Bifidobacteria infantis
1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge
Placebo Comparator: Placebo
A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).
Dilute Nutramigen formula
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316510
|Contact: Mark A Underwood, MDfirstname.lastname@example.org|
|Contact: Robyn Borghese, MDemail@example.com|
|United States, California|
|UC Davis Children's Hospital||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Robyn Borghese, MD 916-703-3050 firstname.lastname@example.org|
|Contact: Majid Mirmiran, MD, PhD 916-762-2780 email@example.com|
|Principal Investigator: Mark Underwood, MD|
|Principal Investigator:||Mark A Underwood, MD||UC Davis|