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Probiotics in Infants With Gastroschisis

This study is currently recruiting participants.
Verified March 2011 by University of California, Davis
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
  Purpose

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.


Condition Intervention
Gastroschisis
 Dietary Supplement: Bifidobacteria infantis
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Probiotics in Infants With Gastroschisis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: Initial discharge from the hospital ] [ Designated as safety issue: No ]
    Number of days from surgery until discharge


Estimated Enrollment: 24
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)
Arms Assigned Interventions
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).
 Other: Placebo
Dilute Nutramigen formula

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 2 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316510

Contacts
Contact: Mark A Underwood, MD 762-7892 mark.underwood@ucdmc.ucdavis.edu
Contact: Robyn Borghese, MD 703-3050 robyn.borghese@ucdmc.ucdavis.edu

Locations
United States, California
UC Davis Children's Hospital Recruiting
Sacramento, California, United States, 95817
Contact: Robyn Borghese, MD     916-703-3050     robyn.borghese@ucdmc.ucdavis.edu    
Contact: Majid Mirmiran, MD, PhD     916-762-2780     majid.mirmiran@ucdmc.ucdavis.edu    
Principal Investigator: Mark Underwood, MD            
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Mark A Underwood, MD UC Davis
  More Information

No publications provided

Responsible Party: Mark Underwood MD, Department of Pediatrics, UC Davis School of Medicine
ClinicalTrials.gov Identifier: NCT01316510     History of Changes
Other Study ID Numbers: 201018539
Study First Received: March 14, 2011
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Probiotic
bifidobacteria
intestinal motility

Additional relevant MeSH terms:
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
 Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013