N/A
N=24
Probiotics in Infants With Gastroschisis
Gastroschisis
Bottom Line
View on ClinicalTrials.gov: NCT01316510 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Composition of the Fecal Microbiota — 42; 12; 1.1; 14 percentage of total bacteria — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bifidobacteria infantis (Dietary_supplement); Placebo (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composition of the Fecal Microbiota |
42; 12; 1.1; 14 | <0.01 sig |
| SECONDARY Length of Hospital Stay |
32.7; 43.6 | 0.44 |
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.
Eligibility Criteria
Inclusion Criteria
- Gastroschisis
- Born at or transferred to UC Davis Children's hospital
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01316510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.