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NCT01316510 · ClinicalTrials.gov registry record · NA
Probiotics in Infants With Gastroschisis
A NA study, sponsored by University of California, Davis.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT01316510: Completed NA study, sponsored by University of California, Davis.
NCT01316510 is a NA study that has completed, run by University of California, Davis. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316510, a NA study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
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%
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Bifidobacteria infantis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT01316510 record still lists
NCT01316510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01316510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01316510 about?
NCT01316510 is a clinical study titled "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 ...
What is the current status of trial NCT01316510?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2011-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01316510?
The interventions under investigation include: Placebo (OTHER), Bifidobacteria infantis (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01316510?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01316510's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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