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Trial record 10 of 31 for:    "Gastroschisis"

Probiotics in Infants With Gastroschisis

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ClinicalTrials.gov Identifier: NCT01316510
Recruitment Status : Completed
First Posted : March 16, 2011
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Gastroschisis
Interventions Dietary Supplement: Bifidobacteria infantis
Other: Placebo
Enrollment 24
Recruitment Details Infants were eligible for the study if they had confirmed gastroschisis at birth and gestational age at birth > 34 weeks. Parents were approached prior to or after the birth. All infants enrolled were inpatients in the NICU at UC Davis Children's Hospital in Sacramento CA. Enrollment began in March 2011 and was completed in Feb 2015.
Pre-assignment Details  
Arm/Group Title Bifidobacterium Infantis Placebo
Hide Arm/Group Description

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

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

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

Placebo: Dilute Nutramigen formula

Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Bifidobacterium Infantis Placebo Total
Hide Arm/Group Description

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

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

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

Placebo: Dilute Nutramigen formula

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Gestational Age Number Analyzed 12 participants 12 participants 24 participants
36.5
(35.75 to 37)
37
(36 to 37)
37
(36 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
5
  41.7%
6
  50.0%
11
  45.8%
Male
7
  58.3%
6
  50.0%
13
  54.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
Birth weight  
Mean (Standard Deviation)
Unit of measure:  Grams
Number Analyzed 12 participants 12 participants 24 participants
2533  (431) 2550  (342) 2541  (380)
1.Primary Outcome
Title Composition of the Fecal Microbiota
Hide Description

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%

Time Frame Final stool sample at 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Final stool sample
Arm/Group Title Bifidobacterium Infantis Placebo
Hide Arm/Group Description:

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

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

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

Placebo: Dilute Nutramigen formula

Overall Number of Participants Analyzed 10 11
Measure Type: Number
Unit of Measure: percentage of total bacteria
Percentage bifidobacteria 42 12
Percentage clostridia 1.1 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bifidobacterium Infantis, Placebo
Comments Primary outcome (percentage of bifidobacteria in the final stool specimen)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Length of Hospital Stay
Hide Description Number of days from surgery until discharge
Time Frame Initial discharge from the hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bifidobacterium Infantis Placebo
Hide Arm/Group Description:

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

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

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

Placebo: Dilute Nutramigen formula

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: days
32.7  (11.1) 43.6  (46.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bifidobacterium Infantis, Placebo
Comments Secondary outcome (length of hospital stay) for all 24 infants (this included two infants with intestinal atresia, both in the placebo group)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bifidobacterium Infantis Placebo
Hide Arm/Group Description

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

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

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

Placebo: Dilute Nutramigen formula

All-Cause Mortality
Bifidobacterium Infantis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bifidobacterium Infantis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bifidobacterium Infantis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Mark Underwood
Organization: UC Davis
Phone: 916-734-8672
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01316510     History of Changes
Other Study ID Numbers: 201018539
First Submitted: March 14, 2011
First Posted: March 16, 2011
Results First Submitted: July 14, 2016
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018