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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Device: Transnasal introduction tube

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 6 to 48 month old infants that can follow fasting requirements

Exclusion Criteria:

• 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:

  1. severe midface trauma and recent nasal, throat, or esophageal surgery.
  2. Esophageal varices, esophageal stricture, and alkaline ingestion
  3. Congenital anatomical defects affecting the gastrointestinal tract, most specifically cleft lip and/or cleft palate.

• Any infant with absolute or relative contraindication to a duodenal biopsy:

  1. post bone marrow transplant
  2. coagulation abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trans Nasal Endomicroscopy Imaging; 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.	Device: Transnasal introduction tube; 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.; Other Names: Microbiome brush; Intestinal potential difference probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to Acquire Intestinal Images in an Unsedated Infant	Can the technology successfully collect images of the small intestine in an unseated infant?	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?	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?	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?	Approximate 90 minute study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants	Measurements including DNA load and microbial composition will be collected.	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	Approximate 90 minute study visit

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Guillermo Tearney, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: OCT
• Other Study ID Numbers: 2021P003264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes