Probiotics in Infants With Gastroschisis

Not Applicable

Completed

• Conditions: Gastroschisis
• Interventions: Dietary Supplement: Bifidobacteria infantis; Other: Placebo

• Registration Number: NCT01316510
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-16
• Primary Completion: 2015-02
• Study Completion: 2015-08
• Results First Submitted: 2016-07-14
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-03
• Last Update Submitted: 2017-10-03
• Results First Posted: 2018-07-13
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bifidobacteria infantis	Bifidobacteria infantis	1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)
Placebo	Placebo	A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).

Primary Outcome Measures

Name	Time	Method
Composition of the Fecal Microbiota	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

Name	Time	Method
Length of Hospital Stay	Initial discharge from the hospital	Number of days from surgery until discharge

Trial Locations

Locations (1)

UC Davis Children's Hospital; 🇺🇸 Sacramento, California, United States