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

Mass General Brigham

Status: Terminated

Conditions: Healthy

Treatments: Device: Transnasal introduction tube

Study type: Interventional

Funder types: Other

Identifiers

NCT05857488

2021P003264

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 6 to 48 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Trans Nasal Endomicroscopy Imaging

Experimental group

Description:

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.

Treatment:

Device: Transnasal introduction tube