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

NCT04901546 | Completed

• 1 other identifier: 58102
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Atresia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Immune System Profile

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

• Change in Fecal Metabolome Profile

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

• Change in Blood Metabolome Profile

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

Study Arms (2)

Infants with Esophageal Atresia

EXPERIMENTAL

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.

Other: Patient's own saliva

Comparison Infants without Esophageal Atresia

NO INTERVENTION

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

Interventions

Patient's own saliva OTHER

Infants with esophageal atresia will be given their own saliva

Infants with Esophageal Atresia

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Neonates matched for gestational age without EA, also anticipated to require surgery (Infants \>=32 weeks), or also premature (\<32 weeks)
• sepsis
• admission to study hospital after 7 days old
• expected length of stay \<2 weeks

Sponsors & Collaborators

• Stanford University: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

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

Study Officials

• David Relman, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Pearl Houghteling

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine - Infectious Disease

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 25, 2021
• Study Start: May 15, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)