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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    10
  • sponsor
    Massachusetts General Hospital
Updated on 1 August 2021
small intestine

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

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.

Details
Condition Gastroenteritis, Intestinal Diseases, Inflammatory bowel disease, Crohn's Disease, Inflammatory Disease, Inflammatory Disorder, Crohn's Disease (Pediatric), Bowel Dysfunction, Permeability; Increased, Environmental Enteropathy, Permeability; Increased, inflammatory bowel diseases, crohns disease, Permeability; Increased, Permeability; Increased, Permeability; Increased, Permeability; Increased
Treatment IPD Probe via TNIT
Clinical Study IdentifierNCT04565821
SponsorMassachusetts General Hospital
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Subjects with a history of upper respiratory disease or surgery
Subjects with a history of upper gastrointestinal surgery
Subjects with upper respiratory infection at least 7 days prior to the procedure
Subjects 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
Subjects with a history of or being on medications that delay gastric emptying
Subjects on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders
Subjects using nasal steroids or any steroids for environmental allergies
Subjects with suspected or diagnosed HIV
Subjects with a recent use of Antibiotics within the past 4 weeks
Subjects with a current or history of Alcoholism
Subjects with suspected or diagnosed Hep B or Hep C
Subjects with suspected or diagnosed Galactosemia
Subjects enrolled in clinical trials involving interventions that affect Intestinal Permeability
Subjects with uncontrolled Diabetes Mellitus 1 & Diabetes Mellitus 2
Subjects currently taking H2 Histamine Antagonists (such as Pepcid, Axid, Tagamet, Zantac, etc)
Subjects currently taking Mast Cell stabilizers
Subjects currently Lactating due to Pregnancy
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