Probiotics in Infants With Gastroschisis

University of California (UC) Davis

Status: Completed

Conditions: Gastroschisis

Treatments: Dietary Supplement: Bifidobacteria infantis; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01316510

201018539

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: Under 2 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Bifidobacteria infantis

Active Comparator group

Description:

1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)

Treatment:

Dietary Supplement: Bifidobacteria infantis

Placebo

Placebo Comparator group

Description:

A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).

Treatment:

Other: Placebo