Status:
COMPLETED
Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Esophageal Atresia
Eligibility:
All Genders
Up to 3 years
Phase:
NA
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 (dir...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04901546
Start Date
May 15 2021
End Date
April 8 2022
Last Update
April 13 2023
Active Locations (1)
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1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304