Clinical trial NCT05857488: Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at University of Virginia (UVa)
Official title: Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at UVa
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Keywords: OCT
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2023-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ability to acquire gastrointestinal images in an unsedated infant
timeFrame: Approximate 90 minute study visit
measure: Ability for unsedated infant subjects to tolerate the device
timeFrame: Approximate 90 minute study visit
measure: Ability to visualize gastrointestinal features in unsedated infants
timeFrame: Approximate 90 minute study visit
measure: Ability to acquire microbiome brush and intestinal potential difference samples
timeFrame: Approximate 90 minute study visit
Secondary outcomes:
measure: Amount and composition of microbial samples acquired via microbiome brush sampling in unsedated infants
timeFrame: Approximate 90 minute study visit
measure: Ability to collect intestinal potential difference measurements in various locations in the gastrointestinal tract of unsedated infants
timeFrame: Approximate 90 minute study visit
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Children's Hospital
state: Virginia
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: