Trial Outcomes & Findings for Probiotics in Infants With Gastroschisis (NCT NCT01316510)

Results Overview

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%

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Final stool sample at 6 weeks

Results posted on

2018-07-13

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Bifidobacterium Infantis 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	Placebo A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). Placebo: Dilute Nutramigen formula
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Probiotics in Infants With Gastroschisis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bifidobacterium Infantis n=12 Participants 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	Placebo n=12 Participants A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). Placebo: Dilute Nutramigen formula	Total n=24 Participants Total of all reporting groups
Age, Customized Gestational Age	36.5 Weeks n=5 Participants	37 Weeks n=7 Participants	37 Weeks n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Birth weight	2533 Grams STANDARD_DEVIATION 431 • n=5 Participants	2550 Grams STANDARD_DEVIATION 342 • n=7 Participants	2541 Grams STANDARD_DEVIATION 380 • n=5 Participants

PRIMARY outcome

Timeframe: Final stool sample at 6 weeks

Population: Final stool sample

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%

Outcome measures

Outcome measures
Measure	Bifidobacterium Infantis n=10 Participants 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	Placebo n=11 Participants A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). Placebo: Dilute Nutramigen formula
Composition of the Fecal Microbiota Percentage bifidobacteria	42 percentage of total bacteria	12 percentage of total bacteria
Composition of the Fecal Microbiota Percentage clostridia	1.1 percentage of total bacteria	14 percentage of total bacteria

SECONDARY outcome

Timeframe: Initial discharge from the hospital

Number of days from surgery until discharge

Outcome measures

Outcome measures
Measure	Bifidobacterium Infantis n=12 Participants 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	Placebo n=12 Participants A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). Placebo: Dilute Nutramigen formula
Length of Hospital Stay	32.7 days Standard Deviation 11.1	43.6 days Standard Deviation 46.5

Adverse Events

Bifidobacterium Infantis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Underwood

UC Davis

Phone: 916-734-8672

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place