Esophageal AtresiaNCT04901546
Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome
A study testing Patient's own saliva in people with Esophageal Atresia, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Esophageal Atresia
- What is being tested?
- Patient's own saliva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2021to 8 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- sepsis
- admission to study hospital after 7 days old
- expected length of stay <2 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
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.
Read the 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.
- Conditions
- Esophageal Atresia
- Being tested
- Patient's own saliva
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient's own salivaOther
Infants with esophageal atresia will be given their own saliva
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient's own saliva |
| Comparison Infants without Esophageal Atresia | No intervention | Infants do not have EA and thus can swallow their own saliva. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From birth until discharge from the hospital, up to 1 year
Secondary outcomes (3)
Change in Immune System Profile
Determine immune cell profiles using mass cytometry (CyTOF)
Measured: From birth until discharge from the hospital, up to 1 year
Change in Fecal Metabolome Profile
Measure metabolites in the stool using mass spectrometry
Measured: From birth until discharge from the hospital, up to 1 year
Change in Blood Metabolome Profile
Measure metabolites in the blood using mass spectrometry
Measured: From birth until discharge from the hospital, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start15 May 2021
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, David A. Relman, Stanford University
- Investigators
- David Relman, MD, Principal investigator, Stanford UniversityPearl Houghteling, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901546
- Sponsor's protocol ID
- 58102
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome
- ClinicalTrials.gov ID
- NCT04901546
- Acronym / sponsor ID
- 58102
- Conditions
- Esophageal Atresia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 15 May 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Infants with Esophageal Atresia | Experimental | Other: Patient's own salivaStarting at 3 weeks, infants will be administered 1 mL of their own saliva via gastrostomy tube, with each feed (8x/day) for one week. |
| Comparison Infants without Esophageal Atresia | No intervention | –Infants do not have EA and thus can swallow their own saliva. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- sepsis
- admission to study hospital after 7 days old
- expected length of stay <2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient's own salivaInfants with esophageal atresia will be given their own saliva | Other | Infants with Esophageal Atresia |
Primary outcome
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)
3 secondary outcomes
Change in Immune System Profile
Time frame: From birth until discharge from the hospital, up to 1 year
Change in Fecal Metabolome Profile
Time frame: From birth until discharge from the hospital, up to 1 year
Change in Blood Metabolome Profile
Time frame: From birth until discharge from the hospital, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Relman, MD principal investigator
Stanford University
Pearl Houghteling principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient's own saliva in people with Esophageal Atresia, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbial Community Structure (time frame: From birth until discharge from the hospital, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.