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Probiotics in Infants With Gastroschisis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316510
Recruitment Status : Unknown
Verified January 2015 by University of California, Davis.
Recruitment status was:  Recruiting
First Posted : March 16, 2011
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment
Gastroschisis Dietary Supplement: Bifidobacteria infantis Other: Placebo

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Probiotics in Infants With Gastroschisis
Study Start Date : March 2011
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Composition of the fecal microbiota [ Time Frame: every two weeks for 6 weeks ]
    Stools will be collected from messy diapers.

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Initial discharge from the hospital ]
    Number of days from surgery until discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01316510

Contact: Mark A Underwood, MD 762-7892
Contact: Robyn Borghese, MD 703-3050

United States, California
UC Davis Children's Hospital Recruiting
Sacramento, California, United States, 95817
Contact: Robyn Borghese, MD    916-703-3050   
Contact: Majid Mirmiran, MD, PhD    916-762-2780   
Principal Investigator: Mark Underwood, MD         
Sponsors and Collaborators
University of California, Davis
Principal Investigator: Mark A Underwood, MD UC Davis

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of California, Davis Identifier: NCT01316510     History of Changes
Other Study ID Numbers: 201018539
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by University of California, Davis:
intestinal motility

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