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

Esophageal Atresia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901546
• Other study ID #: 58102
• Status: Completed
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Atresia

Intervention

Other:
• Patient's own saliva
Infants with esophageal atresia will be given their own saliva

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From birth until discharge from the hospital, up to 1 year
Secondary	Change in Immune System Profile	Determine immune cell profiles using mass cytometry (CyTOF)	From birth until discharge from the hospital, up to 1 year
Secondary	Change in Fecal Metabolome Profile	Measure metabolites in the stool using mass spectrometry	From birth until discharge from the hospital, up to 1 year
Secondary	Change in Blood Metabolome Profile	Measure metabolites in the blood using mass spectrometry	From birth until discharge from the hospital, up to 1 year