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OpenTrials
Completed

NCT Number: NCT04901546

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

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.

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Key information

Conditions

Esophageal Atresia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient's own saliva

Other

Infants with esophageal atresia will be given their own saliva

Primary outcomes

  1. Change in Gut Microbial Community Structure

    Time frame: 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 outcomes

  1. Change in Immune System Profile

    Time frame: From birth until discharge from the hospital, up to 1 year

    Determine immune cell profiles using mass cytometry (CyTOF)

  2. Change in Fecal Metabolome Profile

    Time frame: From birth until discharge from the hospital, up to 1 year

    Measure metabolites in the stool using mass spectrometry

  3. Change in Blood Metabolome Profile

    Time frame: From birth until discharge from the hospital, up to 1 year

    Measure metabolites in the blood using mass spectrometry

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Thrasher Research Fund

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 25, 2021
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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