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

Stopped early · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT05857488

Run by

Massachusetts General Hospital

People needed

1

Starts

2022-01-01

Expected to finish

2022-06-17

Last updated by the study team

2025-08-08

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 6 to 48 month old infants that can follow fasting requirements

You may not qualify if…

• 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

Where it is running

• University of Virginia Children's Hospital — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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