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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifidobacteria infantis | Active Comparator | 1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first) |
|
| Placebo | Placebo Comparator | A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacteria infantis | Dietary Supplement | 1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Number of days from surgery until discharge | Initial discharge from the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Underwood, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Children's Hospital | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26545203 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). Placebo: Dilute Nutramigen formula |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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% | Final stool sample | Posted | Number | percentage of total bacteria | Final stool sample at 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Underwood | UC Davis | 916-734-8672 | munderwood@ucdavis.edu |
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| ID | Term |
|---|---|
| D020139 | Gastroschisis |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Placebo | Other | Dilute Nutramigen formula |
|
| Placebo |
A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). Placebo: Dilute Nutramigen formula |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Birth weight | Mean | Standard Deviation | Grams |
|
A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). Placebo: Dilute Nutramigen formula |
|
|
|
| Secondary | Length of Hospital Stay | Number of days from surgery until discharge | Posted | Mean | Standard Deviation | days | Initial discharge from the hospital |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo | A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm). Placebo: Dilute Nutramigen formula | 0 | 12 | 0 | 12 |
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| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |