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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Transnasal introduction tube


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans Nasal Endomicroscopy Imaging<br>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<br>* 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.<br>* Other names: Intestinal potential difference probe;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 gastrointestinal features in unsedated infants | Can the technology successfully visualize gastrointestinal features 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT