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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04565821
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Inflammatory Disease Permeability; Increased Crohn Disease Inflammatory Bowel Diseases Environmental Enteropathy Device: IPD Probe via TNIT Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Anita Chung, RN 617-724-4515 Tearneylabtrials@partners.org
Contact: Anna Gao, RN 617-643-6092 Tearneylabtrials@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anita Chung, RN    617-724-4515    Tearneylabtrials@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Guillermo Tearney, M.D, PhD. Massachusetts General Hospital
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Responsible Party: Guillermo Tearney, Principal Investigator - MD, PhD, FACC, FCAP, FNAI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04565821    
Other Study ID Numbers: 2020P000158
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
OCT
Optical Coherence Tomography
TNIT
Trans Nasal Introduction Tube
IPD
Intestinal Potential Difference
Leaky Gut
Gastrointestinal Permeability
GI Permeability
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases