Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe

NCT04565821 | Active Not Recruiting FDA Device

• 1 other identifier: 2020P000158
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability

Conditions

Inflammatory Disease; Permeability; Increased; Crohn Disease; Inflammatory Bowel Diseases; Environmental Enteropathy

Keywords

OCT; Optical Coherence Tomography; TNIT; Trans Nasal Introduction Tube; IPD; Intestinal Potential Difference; Leaky Gut; Gastrointestinal Permeability; GI Permeability

Outcome Measures

Primary Outcomes (3)

• Baseline IPD readings

  Feasibility will be measured by the IPD probes ability to, accurately and in real-time, measure voltages that are consistent with literature for the tissue we are testing

  The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.

• IPD readings after Glucose/Galactose infusion

  the IPD probe's ability to measure a more positive reading when Glucose or Galactose have been perfused.

  The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.

• Image Quality

  Image quality will be determined by our study staff's ability to discern the various tissues' architecture and morphology and the resolution of the images recorded. This is a qualitative measurement to determine feasibility of the device.

  Imaging data is collected during the procedure, and analyzed within 1 year of collection.

Study Arms (1)

Feasibility of trans-nasal IPD probe

EXPERIMENTAL

The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability

Device: IPD Probe via TNIT

Interventions

IPD Probe via TNIT DEVICE

A total of 10 healthy adult volunteers will be enrolled in this study. All consented participants will be receive the same intervention. A Nasal tube will be inserted through nares until reaching the small intestine. This will be confirmed by m-mode OCT. Once secured, we will start infusing Ionic solution into the intestine so that IPD Probe can measure the potential difference between this and the control reading. The control reading is measured by infusing the same ionic solution subcutaneously on large muscle groups.

Feasibility of trans-nasal IPD probe

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects
• Participant must be 18 to 60 years of age
• Participant must be able to consent to the procedure
• Participant must fast (no solid food) for at least 8 hours prior to the procedure

You may not qualify if:

• Participants with a history of upper respiratory disease or surgery
• Participants with a history of upper gastrointestinal surgery
• Partcipants with upper respiratory infection at least 7 days prior to the procedure
• Participants with any contraindications to the placement of the NJ tube including deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc.
• Participants with a history of or being on medications that delay gastric emptying.
• Participants on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
• Participants using nasal steroids or any steroids for environmental allergies
• Participants with suspected or diagnosed HIV
• Participants with a recent use of Antibiotics within the past 4 weeks
• Participants with a current or history of Alcoholism
• Participants with suspected or diagnosed Hep B or Hep C
• Participants enrolled in clinical trials involving interventions that affect Intestinal Permeability
• Participants with uncontrolled Diabetes Mellitus 1 \& Diabetes Mellitus 2
• Participants currently taking H2 Histamine Antagonists (such as Pepcid, Axid, Tagamet, Zantac, etc)
• Participants currently taking Mast Cell stabilizers

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Guillermo Tearney, M.D, PhD.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: September 25, 2020
• Study Start: November 12, 2020
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)