Trials / Completed
CompletedNCT01316510
Probiotics in Infants With Gastroschisis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- All
- Age
- 2 Weeks
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2015-02-01
- Completion
- 2015-08-01
- First posted
- 2011-03-16
- Last updated
- 2018-07-13
- Results posted
- 2018-07-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01316510. Inclusion in this directory is not an endorsement.