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

NCT05857488 | Terminated Results FDA Device

• 1 other identifier: 2021P003264
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

OCT

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants

  Approximate 90 minute study visit

• Ability to Collect Intestinal Potential Difference Measurements in Various Locations in the Gastrointestinal Tract of Unsedated Infants

  Approximate 90 minute study visit

Study Arms (1)

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.

Device: Transnasal introduction tube

Interventions

Transnasal introduction tube DEVICE

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.

Also known as: Microbiome brush, Intestinal potential difference probe

Trans Nasal Endomicroscopy Imaging

Eligibility Criteria

• Age: 6 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 48 month old infants that can follow fasting requirements

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

University of Virginia Children's Hospital

Charlottesville, Virginia, 22903, United States

Location

Results Point of Contact

• Title: Guillermo Tearney, MD, PhD
• Organization: Massachusetts General Hospital

gtearney@mgb.org

617-724-2979

Study Officials

• Guillermo Tearney, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: May 12, 2023
• Study Start: January 1, 2022
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)