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

Primary Purpose

Esophageal Atresia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Patient's own saliva

About this trial

This is an interventional basic science trial for Esophageal Atresia

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lucile Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Infants with Esophageal Atresia

Comparison Infants without Esophageal Atresia

Arm Description

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.

Infants do not have EA and thus can swallow their own saliva.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in Immune System Profile

Determine immune cell profiles using mass cytometry (CyTOF)

Change in Fecal Metabolome Profile

Measure metabolites in the stool using mass spectrometry

Change in Blood Metabolome Profile

Measure metabolites in the blood using mass spectrometry

Full Information

NCT ID

NCT04901546

First Posted

April 21, 2021

Last Updated

April 11, 2023

Sponsor

Stanford University

Collaborators

Thrasher Research Fund

1. Study Identification

Unique Protocol Identification Number

NCT04901546

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 15, 2021 (Actual)

Primary Completion Date

April 8, 2022 (Actual)

Study Completion Date

April 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Thrasher Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Atresia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Infants with esophageal atresia (EA) and comparison infants without esophageal atresia (but also in the neonatal intensive care unit, NICU) will be recruited. Infants with EA will be given their own saliva for 1 week, with every feed. Infants without EA will receive usual care. All subjects will have samples collected according to the same schedule. Mothers of infants will also be recruited and have samples collected in order to understand the sources of the infant's gut microbiome.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Infants with Esophageal Atresia

Arm Type

Experimental

Arm Description

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.

Arm Title

Comparison Infants without Esophageal Atresia

Arm Type

No Intervention

Arm Description

Infants do not have EA and thus can swallow their own saliva.

Intervention Type

Other

Intervention Name(s)

Patient's own saliva

Intervention Description

Infants with esophageal atresia will be given their own saliva

Primary Outcome Measure Information:

Title

Change in Gut Microbial Community Structure

Description

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

Secondary Outcome Measure Information:

Title

Change in Immune System Profile

Description

Determine immune cell profiles using mass cytometry (CyTOF)

Time Frame

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

Title

Change in Fecal Metabolome Profile

Description

Measure metabolites in the stool using mass spectrometry

Time Frame

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

Title

Change in Blood Metabolome Profile

Description

Measure metabolites in the blood using mass spectrometry

Time Frame

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Relman, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pearl Houghteling

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lucile Packard Children's Hospital

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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