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Probiotics in Infants With Gastroschisis

Primary Purpose

Gastroschisis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bifidobacteria infantis

Placebo

About this trial

This is an interventional other trial for Gastroschisis focused on measuring Probiotic, bifidobacteria, intestinal motility

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Gastroschisis
Born at or transferred to UC Davis Children's hospital

Exclusion Criteria:

None

Sites / Locations

UC Davis Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bifidobacteria infantis

Placebo

Arm Description

1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)

A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Length of Hospital Stay

Number of days from surgery until discharge

Full Information

NCT ID

NCT01316510

First Posted

March 14, 2011

Last Updated

October 3, 2017

Sponsor

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT01316510

Brief Title

Probiotics in Infants With Gastroschisis

Official Title

Probiotics in Infants With Gastroschisis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroschisis

Keywords

Probiotic, bifidobacteria, intestinal motility

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bifidobacteria infantis

Arm Type

Active Comparator

Arm Description

1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).

Intervention Type

Dietary Supplement

Intervention Name(s)

Bifidobacteria infantis

Intervention Description

1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Dilute Nutramigen formula

Primary Outcome Measure Information:

Title

Composition of the Fecal Microbiota

Description

Time Frame

Final stool sample at 6 weeks

Secondary Outcome Measure Information:

Title

Length of Hospital Stay

Description

Number of days from surgery until discharge

Time Frame

Initial discharge from the hospital

10. Eligibility

Sex

All

Maximum Age & Unit of Time

2 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Gastroschisis Born at or transferred to UC Davis Children's hospital Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark A Underwood, MD

Organizational Affiliation

UC Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Davis Children's Hospital

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26545203

Citation

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.

Results Reference

derived

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Probiotics in Infants With Gastroschisis

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