Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04565821
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2020-08-11
Brief Title:
Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 bloodstream1 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 Crohns 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 disaccharidemonosaccharide 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 eg 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
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 disaccharidemonosaccharide 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None