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Trial record 10 of 31 for:    "Gastroschisis"

Probiotics in Infants With Gastroschisis

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ClinicalTrials.gov Identifier: NCT01316510
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
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 Phase
Gastroschisis Dietary Supplement: Bifidobacteria infantis Other: Placebo Not Applicable

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.

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

Resource links provided by the National Library of Medicine


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: Final stool sample at 6 weeks ]

    Stools will be collected from messy diapers.

    Percentage bifidobacteria = total bifidobacteria per Group divided by the total bacteria per Group multiplied by 100% Percentage clostridia = total clostridia per Group divided by the total bacteria per Group multiplied by 100%



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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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 ClinicalTrials.gov identifier (NCT number): NCT01316510


Locations
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United States, California
UC Davis Children's Hospital
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Mark A Underwood, MD UC Davis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01316510     History of Changes
Other Study ID Numbers: 201018539
First Posted: March 16, 2011    Key Record Dates
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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