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Completed

NCT Number: NCT01316510

Probiotics in Infants With Gastroschisis

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.

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Key information

Conditions

Gastroschisis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Musculoskeletal Abnormalities Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

Up to 2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Children's Hospital

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Bifidobacteria infantis

Dietary Supplement

1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge

Placebo

Other

Dilute Nutramigen formula

Primary outcomes

  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 outcomes

  1. Length of Hospital Stay

    Time frame: Initial discharge from the hospital

    Number of days from surgery until discharge

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 16, 2011
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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