N/A
Completed N=24
Probiotics in Infants With Gastroschisis
Source: ClinicalTrials.gov NCT01316510 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Composition of the Fecal Microbiota — 42; 12; 1.1; 14 percentage of total bacteria — p=<0.01
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.
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 |
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. Informational only — not medical advice.