Probiotics in Infants With Gastroschisis
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
July 13, 2018
CompletedJuly 13, 2018
October 1, 2017
3.9 years
March 14, 2011
July 14, 2016
October 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composition of the Fecal Microbiota
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%
Final stool sample at 6 weeks
Secondary Outcomes (1)
Length of Hospital Stay
Initial discharge from the hospital
Study Arms (2)
Bifidobacteria infantis
ACTIVE COMPARATOR1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)
Placebo
PLACEBO COMPARATORA dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).
Interventions
1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge
Eligibility Criteria
You may qualify if:
- Gastroschisis
- Born at or transferred to UC Davis Children's hospital
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Davis Children's Hospital
Sacramento, California, 95817, United States
Related Publications (1)
Powell WT, Borghese RA, Kalanetra KM, Mirmiran M, Mills DA, Underwood MA. Probiotic Administration in Infants With Gastroschisis: A Pilot Randomized Placebo-Controlled Trial. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):852-857. doi: 10.1097/MPG.0000000000001031.
PMID: 26545203DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Underwood
- Organization
- UC Davis
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Underwood, MD
UC Davis
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 16, 2011
Study Start
March 1, 2011
Primary Completion
February 1, 2015
Study Completion
August 1, 2015
Last Updated
July 13, 2018
Results First Posted
July 13, 2018
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share