Esophageal Atresia
Conditions
Brief summary
The purpose of this study is to understand changes of the gut microbiome due to esophageal atresia. The intervention will be to give a patient his or her own saliva through their gastrostomy tube (directly into the stomach) to observe if this can normalize microbial colonization of the gut.
Detailed description
After being informed about the study and its overall risks, parents will be given the option to enroll their infant. Participants (infants) with esophageal atresia and a gastrostomy tube will be given their own saliva through their gastrostomy tube, directly into the stomach. Samples of saliva and stool will be collected from these infants, and from a comparison group without esophageal atresia, as well as blood and urine to look for changes in immune responses and in metabolism.
Interventions
OTHERPatient's own saliva
Infants with esophageal atresia will be given their own saliva
Sponsors
Thrasher Research Fund
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Infants with esophageal atresia (EA) and comparison infants without esophageal atresia (but also in the neonatal intensive care unit, NICU) will be recruited. Infants with EA will be given their own saliva for 1 week, with every feed. Infants without EA will receive usual care. All subjects will have samples collected according to the same schedule. Mothers of infants will also be recruited and have samples collected in order to understand the sources of the infant's gut microbiome.
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
* Neonates with Esophageal Atresia (All, no
Exclusion criteria
); maximum age at enrollment is 3 months. * Neonates matched for gestational age without EA, also anticipated to require surgery (Infants \>=32 weeks), or also premature (\<32 weeks)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Microbial Community Structure | From birth until discharge from the hospital, up to 1 year | Evaluate community structure and differential abundances of dominant taxa and of key taxa to the newborn (e.g., Bifidobacterium, Bacteroides, Lactobacillus, Staphylococcus and Enterobacteriaceae) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Immune System Profile | From birth until discharge from the hospital, up to 1 year | Determine immune cell profiles using mass cytometry (CyTOF) |
| Change in Fecal Metabolome Profile | From birth until discharge from the hospital, up to 1 year | Measure metabolites in the stool using mass spectrometry |
| Change in Blood Metabolome Profile | From birth until discharge from the hospital, up to 1 year | Measure metabolites in the blood using mass spectrometry |
Countries
United States
Outcome results
None listed