Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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)
Exclusion Criteria (only for infants without EA):
- sepsis
- admission to study hospital after 7 days old
- expected length of stay <2 weeks
Trial design
Primary purpose
Allocation
Interventional model
Masking
52 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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