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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04565821
• Other study ID #: 2020P000158
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.