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

Not Applicable

• Conditions: Healthy
• Interventions: Device: Transnasal introduction tube

• Registration Number: NCT05857488
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-03-09
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-04
• Last Update Submitted: 2023-05-04
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trans Nasal Endomicroscopy Imaging	Transnasal introduction tube	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.

Primary Outcome Measures

Name	Time	Method
Ability to visualize gastrointestinal features in unsedated infants	Approximate 90 minute study visit	Can the technology successfully visualize gastrointestinal features in unsedated infants?
Ability for unsedated infant subjects to tolerate the device	Approximate 90 minute study visit	Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort?
Ability to acquire gastrointestinal images in an unsedated infant	Approximate 90 minute study visit	Can the technology successfully collect gastrointestinal images in an unsedated infant?
Ability to acquire microbiome brush and intestinal potential difference samples	Approximate 90 minute study visit	Can the technology successfully collect microbiome brush and/or intestinal potential differences samples?

Secondary Outcome Measures

Name	Time	Method
Ability to collect intestinal potential difference measurements in various locations in the gastrointestinal tract of unsedated infants	Approximate 90 minute study visit	Intestinal potential difference measurements will be collected at various locations to determine the feasibility of measuring IPD in unsedated infants
Amount and composition of microbial samples acquired via microbiome brush sampling in unsedated infants	Approximate 90 minute study visit	Measurements including DNA load and microbial composition will be collected.

Trial Locations

Locations (1)

University of Virginia Children's Hospital; 🇺🇸 Charlottesville, Virginia, United States