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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Permeability; Increased; Inflammatory Disease; Environmental Enteropathy
• Intervention / Treatment: Device: IPD Probe via TNIT

Detailed Description

Increased gastrointestinal (GI) permeability is associated to several GI conditions that affect millions of people worldwide. Healthy intestinal walls limit only specific molecules to cross into the body. "Leaky gut" is a condition of unregulated and increased gut permeability that allows unwanted antigens, pathogens and microbial toxins into the bloodstream(1). This in turn leads to a subsequent immune response that includes the production of inflammatory mediators. Leaky gut is a key feature in celiac disease, Crohn's disease, inflammatory bowel disease (IBD), and environmental enteropathy and have been associated with systemic diseases including type 1 diabetes, autoimmune hepatitis, and systemic lupus erythematosus (SLE).

The current gold standard for measuring intestinal permeability is the sugar ratio test. Non-metabolized sugars of different molecular sizes are orally administered and the amount of sugar molecules absorbable across the gut lining is then quantified by measuring their relative concentrations in urine. In healthy subjects, low to none of the large-molecule disaccharides can be taken into the circulatory system, while the small-molecule monosaccharides can readily diffuse into the bloodstream. This results in low disaccharide/monosaccharide (DM) ratios for healthy subjects. Subjects with the leaky gut conditions exhibit high DM ratios in their urine. However, the sugar ratio test has low specificity, does not provide specific information on etiology, is challenging to implement when pristine urine samples cannot be collected (e.g. infants), and does not account for spatially heterogeneous disease.

An alternative approach for measuring mucosal permeability is through measuring the voltage across the intestinal wall (Intestinal potential difference; IPD) that changes with intestinal permeability. The Tearney lab has developed an IPD measuring device (IPD probe) that can be deployed trans-nasally and can measure the intestinal potential difference in real time at selected locations of the gut. The probe contains a central channel that allows us to infuse specific ionic solutions into the gut. The IPD probe also has an optical fiber inside the channel that enables the acquisition of M-mode OCT images. The M-mode OCT images make it possible to determine when the IPD probe is in contact with the tissue.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Participants currently pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Feasibility of trans-nasal IPD probe; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Guillermo Tearney, M.D, PhD., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: OCT; Optical Coherence Tomography; Gastrointestinal Permeability; TNIT; Trans Nasal Introduction Tube; IPD; Intestinal Potential Difference; Leaky Gut; GI Permeability
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2020P000158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No