Probiotics in Infants With Gastroschisis

Gastroschisis Clinical Trial

Official title:

Probiotics in Infants With Gastroschisis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316510
• Other study ID #: 201018539
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: August 2015

Study information

• Verified date: October 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

Inclusion Criteria:

• Gastroschisis

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Gastroschisis

Intervention

Dietary Supplement:
• Bifidobacteria infantis
1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge

Other:
• Placebo
Dilute Nutramigen formula

Locations

Country	Name	City	State
United States	UC Davis Children's Hospital	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Hospital Stay	Number of days from surgery until discharge	Initial discharge from the hospital