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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05857488
• Other study ID #: 2021P003264
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 48 Months

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia Children's Hospital	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to acquire gastrointestinal images in an unsedated infant	Can the technology successfully collect gastrointestinal images in an unsedated infant?	Approximate 90 minute study visit
Primary	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
Primary	Ability to visualize gastrointestinal features in unsedated infants	Can the technology successfully visualize gastrointestinal features in unsedated infants?	Approximate 90 minute study visit
Primary	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	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
Secondary	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