HealthyNCT05857488

Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at UVa

A study testing Transnasal introduction tube in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to demonstrate the feasibility of using the transnasal endomicroscopy (TNE) platform, using intestinal potential difference (IPD) and microbiome brush to evaluate the intestine of unsedated infants. Read more about this study

Who is it for?: Ages 6 to 48 monthsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Transnasal introduction tube
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2022to 17 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 48 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

6 to 48 month old infants that can follow fasting requirements

Who cannot join

Any infant under 6kg of weight since this is the minimum weight for 6.5 F nasogastric (NG) tube
Any infant whose nasal passage cannot reasonably accommodate a 6.5 French nasoduodenal catheter.
Any infants with absolute or relative contraindications to transnasal tubes:
severe midface trauma and recent nasal, throat, or esophageal surgery.
Esophageal varices, esophageal stricture, and alkaline ingestion
Congenital anatomical defects affecting the gastrointestinal tract, most specifically cleft lip and/or cleft palate.

Show all 9Show fewer

Any infant with absolute or relative contraindication to a duodenal biopsy:
post bone marrow transplant
coagulation abnormalities

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia Children's Hospital
Charlottesville, Virginia, 22903

Other trials in United States

About this study

Official title: Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at University of Virginia (UVa)

Read the detailed description

A total of fifteen (15) subjects, infants 6 months of age to 48 months of age will be enrolled in this study.

While the subject is awake and unseated, a catheter with optical coherence tomography (OCT) imaging technology will be introduced transnasally. Images will be acquired while the tube is moved through the subject's GI tract. After imaging is complete, accessory device(s) may be threaded through the catheter to collect samples of the gut microbiome and/or measure intestinal potential difference.

Conditions: Healthy
Being tested: Transnasal introduction tube
Keywords: OCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transnasal introduction tubeDevice
Also called Microbiome brush, Intestinal potential difference probe
Imaging of the GI tract using the transnasal introduction tube and system. Optional gut microbiome sample collection using the microbiome brush and/or intestinal potential difference measurement using the intestinal potential difference probe.

Study groups in NCT05857488
Study group	Role	What they receive
Trans Nasal Endomicroscopy Imaging	Experimental	The subject will have the transnasal introduction tube inserted, and OCT images will be acquired using the OCT compact imaging system. The subject may also undergo a microbiome brushing and/or intestinal potential difference measurement procedure during the study visit. Receives: Device: Transnasal introduction tube

What is being measured

The primary outcome is the main question the study is designed to answer.

Ability to Acquire Intestinal Images in an Unsedated Infant
Can the technology successfully collect images of the small intestine in an unseated infant?
Measured: Approximate 90 minute study visit
Ability for Unsedated Infant Subjects to Tolerate the Device
Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort?
Measured: Approximate 90 minute study visit
Ability to Visualize Features of the Small Intestine in Unsedated Infants.
Can the technology successfully visualize features of the small intestine (villi etc) on OCT in unsedated infants?
Measured: Approximate 90 minute study visit
Ability to Acquire Microbiome Brush and Intestinal Potential Difference Samples
Can the technology successfully collect microbiome brush and/or intestinal potential differences samples?
Measured: Approximate 90 minute study visit

Secondary outcomes (2)

Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants
Measurements including DNA load and microbial composition will be collected.
Measured: Approximate 90 minute study visit
Ability to Collect Intestinal Potential Difference Measurements in Various Locations in the Gastrointestinal Tract of Unsedated Infants
Intestinal potential difference measurements will be collected at various locations to determine the feasibility of measuring IPD in unsedated infants
Measured: Approximate 90 minute study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202217 Jun 2022

First posted12 May 2023
Study start1 Jan 2022
Primary completion17 Jun 2022
Study completion17 Jun 2022

Why it stopped: A shift occurred in the focus of the research, following the emergence of new scientific knowledge regarding the disease. Hence, study was terminated early and withdrawn by the investigator and no further subjects were enrolled.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05857488
Sponsor's protocol ID: 2021P003264
Status last verified: Jul 2025
First submitted: 9 Mar 2023
Last updated: 8 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at University of Virginia (UVa)
ClinicalTrials.gov ID: NCT05857488
Acronym / sponsor ID: 2021P003264
Conditions: Healthy
Keywords: OCT
Study type: Interventional
Recruitment status: TerminatedReason stopped: A shift occurred in the focus of the research, following the emergence of new scientific knowledge regarding the disease. Hence, study was terminated early and withdrawn by the investigator and no further subjects were enrolled.
Enrolment: 1 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Bill and Melinda Gates Foundation
Study start: 1 Jan 2022 (actual)
Primary completion: 17 Jun 2022 (actual)
Study completion: 17 Jun 2022 (actual)
First posted: 12 May 2023 (actual)
Results: Posted 8 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A total of fifteen (15) subjects, infants 6 months of age to 48 months of age will be enrolled in this study.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Trans Nasal Endomicroscopy Imaging	Experimental	Device: Transnasal introduction tubeThe subject will have the transnasal introduction tube inserted, and OCT images will be acquired using the OCT compact imaging system. The subject may also undergo a microbiome brushing and/or intestinal potential difference measurement procedure during the study visit.

Who may qualify

Ages: 6 to 48 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

6 to 48 month old infants that can follow fasting requirements

Key exclusion criteria (9 listed)

Any infant under 6kg of weight since this is the minimum weight for 6.5 F nasogastric (NG) tube
Any infant whose nasal passage cannot reasonably accommodate a 6.5 French nasoduodenal catheter.
Any infants with absolute or relative contraindications to transnasal tubes:
Any infant with absolute or relative contraindication to a duodenal biopsy:

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
Transnasal introduction tubeAlso: Microbiome brush, Intestinal potential difference probeImaging of the GI tract using the transnasal introduction tube and system. Optional gut microbiome sample collection using the microbiome brush and/or intestinal potential difference measurement using the intestinal potential difference probe.	Device	Trans Nasal Endomicroscopy Imaging

Primary outcome

Ability to Acquire Intestinal Images in an Unsedated Infant
Time frame: Approximate 90 minute study visit
Can the technology successfully collect images of the small intestine in an unseated infant?
Ability for Unsedated Infant Subjects to Tolerate the Device
Time frame: Approximate 90 minute study visit
Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort?
Ability to Visualize Features of the Small Intestine in Unsedated Infants.
Time frame: Approximate 90 minute study visit
Can the technology successfully visualize features of the small intestine (villi etc) on OCT in unsedated infants?
Ability to Acquire Microbiome Brush and Intestinal Potential Difference Samples
Time frame: Approximate 90 minute study visit
Can the technology successfully collect microbiome brush and/or intestinal potential differences samples?

2 secondary outcomes

Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants
Time frame: Approximate 90 minute study visit
Ability to Collect Intestinal Potential Difference Measurements in Various Locations in the Gastrointestinal Tract of Unsedated Infants
Time frame: Approximate 90 minute study visit

Results and safety

Results posted to the registry on 8 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trans Nasal Endomicroscopy Imaging	1	1

Primary outcome: Ability to Acquire Intestinal Images in an Unsedated Infant

Time frame: Approximate 90 minute study visit

Population analysed: Procedure was terminated early due to loss of the imaging signal, therefore no OCT images of the small intestines were acquired for this subject, thus this participant could not be assessed for this outcome measure.

Primary outcome: Ability for Unsedated Infant Subjects to Tolerate the Device

Time frame: Approximate 90 minute study visit. Count of participants. Unit: Participants

Measure	Trans Nasal Endomicroscopy Imaging n = 1
Value	1

Population analysed: The procedure was tolerated by the study participant during insertion, imaging of the stomach and removal of the TNIT but the procedure was terminated early due to loss of imaging signal while in the stomach, with no clinical or safety impact on the study participant. Tolerability could not be assessed for some portions of the study procedure including transit to the small intestine, IPD measurements and microbiome brush sample collection.

Primary outcome: Ability to Visualize Features of the Small Intestine in Unsedated Infants.

Time frame: Approximate 90 minute study visit

Population analysed: OCT images were acquired through the TNIT from the esophagus and stomach but the procedure was terminated early due to loss of imaging signal while in the stomach, with no clinical or safety impact on the study participant. Features of the small intestine (villi etc) could not be assessed.

Primary outcome: Ability to Acquire Microbiome Brush and Intestinal Potential Difference Samples

Time frame: Approximate 90 minute study visit

Population analysed: The procedure was terminated early and target samples were not collected in the enrolled subject. Subsequently, a shift occurred in the focus of the research, following the emergence of new scientific knowledge regarding the disease. Hence, study was terminated early and withdrawn by the investigator and no further subjects were enrolled.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The duration of the imaging procedure (approximate 90 minute study visit) and post visit follow up phone call, the following day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trans Nasal Endomicroscopy Imaging	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Guillermo Tearney, MD, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transnasal introduction tube in people with Healthy, run by Massachusetts General Hospital 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 8 Aug 2025. 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?

Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ability to Acquire Intestinal Images in an Unsedated Infant (time frame: Approximate 90 minute study visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05857488.

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 8 Aug 2025.