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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-06-17

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Trans Nasal Endomicroscopy Imaging

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.

Group Type EXPERIMENTAL

Transnasal introduction tube

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Microbiome brush Intestinal potential difference probe

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:

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes