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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05857488
• Collaborator: Bill and Melinda Gates Foundation (Other)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Transnasal introduction tube	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at UVa
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.; Other Names: Microbiome brush Intestinal potential difference probe

Outcome Measures

Primary Outcome Measures

1. Ability to acquire gastrointestinal images in an unsedated infant [Approximate 90 minute study visit]

   Can the technology successfully collect gastrointestinal images in an unsedated infant?

2. Ability for unsedated infant subjects to tolerate the device [Approximate 90 minute study visit]

   Can the unsedated infant subjects tolerate the administration of the device with minimal discomfort?

3. Ability to visualize gastrointestinal features in unsedated infants [Approximate 90 minute study visit]

   Can the technology successfully visualize gastrointestinal features in unsedated infants?

4. Ability to acquire microbiome brush and intestinal potential difference samples [Approximate 90 minute study visit]

   Can the technology successfully collect microbiome brush and/or intestinal potential differences samples?

Secondary Outcome Measures

1. Amount and composition of microbial samples acquired via microbiome brush sampling in unsedated infants [Approximate 90 minute study visit]

   Measurements including DNA load and microbial composition will be collected.

2. Ability to collect intestinal potential difference measurements in various locations in the gastrointestinal tract of unsedated infants [Approximate 90 minute study visit]

   Intestinal potential difference measurements will be collected at various locations to determine the feasibility of measuring IPD in unsedated infants

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 48 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Children's Hospital	Charlottesville	Virginia	United States	22903

Sponsors and Collaborators

• Massachusetts General Hospital
• Bill and Melinda Gates Foundation

Investigators

• Principal Investigator: Guillermo Tearney, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Tearney, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05857488
• Other Study ID Numbers: 2021P003264
• First Posted: May 12, 2023
• Last Update Posted: May 12, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guillermo Tearney, Principal Investigator, Massachusetts General Hospital: OCT

Study Results

No Results Posted as of May 12, 2023