Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome

Not Applicable

Completed

• Conditions: Esophageal Atresia
• Interventions: Other: Patient's own saliva

• Registration Number: NCT04901546
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-21
• Study Start: 2021-05-15
• Study First Submitted QC: 2021-05-20
• Study First Posted: 2021-05-25
• Primary Completion: 2022-04-08
• Study Completion: 2022-04-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants with Esophageal Atresia	Patient's own saliva	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Immune System Profile	From birth until discharge from the hospital, up to 1 year	Determine immune cell profiles using mass cytometry (CyTOF)
Change in Blood Metabolome Profile	From birth until discharge from the hospital, up to 1 year	Measure metabolites in the blood using mass spectrometry

Trial Locations

Locations (1)

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States