Probiotics in Infants With Gastroschisis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Probiotics in Infants With Gastroschisis

Conditions
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Gastroschisis

Intervention / Treatment
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* Dietary Supplement: Bifidobacteria infantis
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastroschisis Born at or transferred to UC Davis Children's hospital Exclusion Criteria: None

Ages Eligible for Study
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Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bifidobacteria infantis<br>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<br>* 1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge<br>|
| Placebo Comparator: Placebo<br>A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). | Other: Placebo<br>* Dilute Nutramigen formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of the Fecal Microbiota | 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% | Final stool sample at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay | Number of days from surgery until discharge | Initial discharge from the hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, bifidobacteria, intestinal motility