Gastroschisis
Conditions
Keywords
Probiotic, bifidobacteria, intestinal motility
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.
Interventions
DIETARY_SUPPLEMENTBifidobacteria infantis
1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge
OTHERPlacebo
Dilute Nutramigen formula
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Weeks
Healthy volunteers
No
Inclusion criteria
* Gastroschisis * Born at or transferred to UC Davis Children's hospital
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composition of the Fecal Microbiota | Final stool sample at 6 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Initial discharge from the hospital | Number of days from surgery until discharge |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Placebo A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).
Placebo: Dilute Nutramigen formula | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Bifidobacterium Infantis | Total | Placebo |
|---|---|---|---|
| Age, Customized Gestational Age | 36.5 Weeks | 37 Weeks | 37 Weeks |
| Birth weight | 2533 Grams STANDARD_DEVIATION 431 | 2541 Grams STANDARD_DEVIATION 380 | 2550 Grams STANDARD_DEVIATION 342 |
| Region of Enrollment United States | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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%
Time frame: Final stool sample at 6 weeks
Population: Final stool sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bifidobacterium Infantis | Composition of the Fecal Microbiota | Percentage bifidobacteria | 42 percentage of total bacteria |
| Bifidobacterium Infantis | Composition of the Fecal Microbiota | Percentage clostridia | 1.1 percentage of total bacteria |
| Placebo | Composition of the Fecal Microbiota | Percentage bifidobacteria | 12 percentage of total bacteria |
| Placebo | Composition of the Fecal Microbiota | Percentage clostridia | 14 percentage of total bacteria |
Comparison: Primary outcome (percentage of bifidobacteria in the final stool specimen)p-value: <0.01t-test, 2 sided
Secondary
Length of Hospital Stay
Number of days from surgery until discharge
Time frame: Initial discharge from the hospital
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bifidobacterium Infantis | Length of Hospital Stay | 32.7 days | Standard Deviation 11.1 |
| Placebo | Length of Hospital Stay | 43.6 days | Standard Deviation 46.5 |
Comparison: Secondary outcome (length of hospital stay) for all 24 infants (this included two infants with intestinal atresia, both in the placebo group)p-value: 0.44t-test, 2 sided