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

Mass General Brigham

Status

Active, not recruiting

Conditions

Permeability; Increased

Environmental Enteropathy

Inflammatory Bowel Diseases

Inflammatory Disease

Crohn Disease

Treatments

Device: IPD Probe via TNIT

Study type

Interventional

Funder types

Other

Identifiers

NCT04565821

2020P000158

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.