Clinical trial NCT04901546: 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
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Atresia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2021-05-25
Enrollment: 52
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in Gut Microbial Community Structure
timeFrame: From birth until discharge from the hospital, up to 1 year
Secondary outcomes:
measure: Change in Immune System Profile
timeFrame: From birth until discharge from the hospital, up to 1 year
measure: Change in Fecal Metabolome Profile
timeFrame: From birth until discharge from the hospital, up to 1 year
measure: Change in Blood Metabolome Profile
timeFrame: From birth until discharge from the hospital, up to 1 year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: David Relman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Pearl Houghteling
role: PRINCIPAL_INVESTIGATOR
References: