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Patient's own saliva for Esophageal Atresia

N/A
Waitlist Available
Led By David Relman, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Neonates with Esophageal Atresia (All, no
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from birth until discharge from the hospital, up to 1 year
Awards & highlights

Study Summary

This trial will study whether giving patients their own saliva through a gastrostomy tube can normalize the gut microbiome and improve gut colonization in patients with esophageal atresia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth until discharge from the hospital, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth until discharge from the hospital, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Gut Microbial Community Structure
Secondary outcome measures
Change in Blood Metabolome Profile
Change in Fecal Metabolome Profile
Change in Immune System Profile

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Infants with Esophageal AtresiaExperimental Treatment1 Intervention
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.
Group II: Comparison Infants without Esophageal AtresiaActive Control1 Intervention
Infants do not have EA and thus can swallow their own saliva.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,568 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,322 Total Patients Enrolled
David Relman, MDPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome
David A. Relman 2021. "Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04901546.
~13 spots leftby Apr 2025
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