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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1
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.
University of Virginia Children's Hospital
Charlottesville, Virginia, United States
Ability to Acquire Intestinal Images in an Unsedated Infant
Can the technology successfully collect images of the small intestine in an unseated infant?
Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: Approximate 90 minute study visit
Amount and Composition of Microbial Samples Acquired Via Microbiome Brush Sampling in Unsedated Infants
Measurements including DNA load and microbial composition will be collected.
Time frame: 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
Time frame: Approximate 90 minute study visit
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