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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.

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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

FieldValue
Enrollment Target 24 participants
Start Date 2011-03
Est. Completion 2015-08
Phase NA
University of California, Davis

657 total trials

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.

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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Source: ClinicalTrials.gov NCT01316510, the US trial registry maintained by the National Library of Medicine. NCT01316510 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.