Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe
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|ClinicalTrials.gov Identifier: NCT04565821|
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Disease Permeability; Increased Crohn Disease Inflammatory Bowel Diseases Environmental Enteropathy||Device: IPD Probe via TNIT||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe|
|Estimated Study Start Date :||October 31, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
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.
- Baseline IPD readings [ Time Frame: The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours. ]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
- IPD readings after Glucose/Galactose infusion [ Time Frame: The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours. ]the IPD probe's ability to measure a more positive reading when Glucose or Galactose have been perfused.
- Image Quality [ Time Frame: Imaging data is collected during the procedure, and analyzed within 1 year of collection. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565821
|Contact: Anita Chung, RN||617-724-4515||Tearneylabtrials@partners.org|
|Contact: Anna Gao, RN||617-643-6092||Tearneylabtrials@partners.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org|
|Principal Investigator:||Guillermo Tearney, M.D, PhD.||Massachusetts General Hospital|