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Probiotics in Infants With Gastroschisis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01316510
First received: March 14, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 14, 2011
March 14, 2011
March 2011
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
Length of hospital stay [ Time Frame: Initial discharge from the hospital ] [ Designated as safety issue: No ]
Number of days from surgery until discharge
Same as current
Not Provided
Not Provided
 
Probiotics in Infants With Gastroschisis
Probiotics in Infants With Gastroschisis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Gastroschisis
  • 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
  • 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)
    Intervention: Dietary Supplement: Bifidobacteria infantis
  • Placebo Comparator: Placebo
    A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
September 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gastroschisis
  • Born at or transferred to UC Davis Children's hospital

Exclusion Criteria:

  • None
Both
up to 2 Weeks
No
Contact: Mark A Underwood, MD 762-7892 mark.underwood@ucdmc.ucdavis.edu
Contact: Robyn Borghese, MD 703-3050 robyn.borghese@ucdmc.ucdavis.edu
United States
 
NCT01316510
201018539
No
Mark Underwood MD, Department of Pediatrics, UC Davis School of Medicine
University of California, Davis
Not Provided
Principal Investigator: Mark A Underwood, MD UC Davis
University of California, Davis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP