An interventional study of Patient's own saliva in Esophageal Atresia, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Stanford University · Not applicable, Interventional, and Basic science
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.
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.
42 studies on the registry are indexed under Esophageal Atresia; 14 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 17 interventional studies indexed under Esophageal Atresia.
Browse Esophageal Atresia studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria (only for infants without EA):
Starting at 3 weeks, infants will be administered 1 mL of their own saliva via gastrostomy tube, with each feed (8x/day) for one week.
Other: Patient's own saliva
Infants do not have EA and thus can swallow their own saliva.
Infants with esophageal atresia will be given their own saliva
Change in Gut Microbial Community Structure
Evaluate community structure and differential abundances of dominant taxa and of key taxa to the newborn (e.g., Bifidobacterium, Bacteroides, Lactobacillus, Staphylococcus and Enterobacteriaceae)
Time frame: From birth until discharge from the hospital, up to 1 year
Change in Immune System Profile
Determine immune cell profiles using mass cytometry (CyTOF)
Time frame: From birth until discharge from the hospital, up to 1 year
Change in Fecal Metabolome Profile
Measure metabolites in the stool using mass spectrometry
Time frame: From birth until discharge from the hospital, up to 1 year
Change in Blood Metabolome Profile
Measure metabolites in the blood using mass spectrometry
Time frame: From birth until discharge from the hospital, up to 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Stanford University