Inflammatory DiseaseNCT04565821
Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe
A study testing IPD Probe via TNIT in people with Inflammatory Disease and Permeability; Increased, run by Massachusetts General Hospital at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Disease, Permeability; Increased, Crohn Disease
- What is being tested?
- IPD Probe via TNIT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2020to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Participant must be 18 to 60 years of age
- Participant must be able to consent to the procedure
- Participant must fast (no solid food) for at least 8 hours prior to the procedure
Who cannot join
- Participants with a history of upper respiratory disease or surgery
- Participants with a history of upper gastrointestinal surgery
- Partcipants with upper respiratory infection at least 7 days prior to the procedure
- Participants 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.
- Participants with a history of or being on medications that delay gastric emptying.
- Participants on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
Show all 16Show fewer
- Participants using nasal steroids or any steroids for environmental allergies
- Participants with suspected or diagnosed HIV
- Participants with a recent use of Antibiotics within the past 4 weeks
- Participants with a current or history of Alcoholism
- Participants with suspected or diagnosed Hep B or Hep C
- Participants enrolled in clinical trials involving interventions that affect Intestinal Permeability
- Participants with uncontrolled Diabetes Mellitus 1 \& Diabetes Mellitus 2
- Participants currently taking H2 Histamine Antagonists (such as Pepcid, Axid, Tagamet, Zantac, etc)
- Participants currently taking Mast Cell stabilizers
- Participants currently pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability
Read the 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.
- Conditions
- Inflammatory Disease, Permeability; Increased, Crohn Disease, Inflammatory Bowel Diseases, Environmental Enteropathy
- Being tested
- IPD Probe via TNIT
- Keywords
- OCT, Optical Coherence Tomography, TNIT, Trans Nasal Introduction Tube, IPD, Intestinal Potential Difference, Leaky Gut, Gastrointestinal Permeability, GI Permeability
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPD Probe via TNITDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility of trans-nasal IPD probe | Experimental | The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability Receives: Device: IPD Probe via TNIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.
IPD readings after Glucose/Galactose infusion
the IPD probe's ability to measure a more positive reading when Glucose or Galactose have been perfused.
Measured: The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.
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.
Measured: Imaging data is collected during the procedure, and analyzed within 1 year of collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start12 Nov 2020
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, M.D, PhD., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565821
- Sponsor's protocol ID
- 2020P000158
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe
- ClinicalTrials.gov ID
- NCT04565821
- Acronym / sponsor ID
- 2020P000158
- Conditions
- Inflammatory Disease, Permeability; Increased, Crohn Disease, Inflammatory Bowel Diseases, Environmental Enteropathy
- Keywords
- OCT, Optical Coherence Tomography, TNIT, Trans Nasal Introduction Tube, IPD, Intestinal Potential Difference, Leaky Gut, Gastrointestinal Permeability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility of trans-nasal IPD probe | Experimental | Device: IPD Probe via TNITThe purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- Participant must be 18 to 60 years of age
- Participant must be able to consent to the procedure
- Participant must fast (no solid food) for at least 8 hours prior to the procedure
Key exclusion criteria (16 listed)
- Participants with a history of upper respiratory disease or surgery
- Participants with a history of upper gastrointestinal surgery
- Partcipants with upper respiratory infection at least 7 days prior to the procedure
- Participants 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.
- Participants with a history of or being on medications that delay gastric emptying.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPD Probe via TNITA 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. | Device | Feasibility of trans-nasal IPD probe |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Tearney, M.D, PhD. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPD Probe via TNIT in people with Inflammatory Disease and Permeability; Increased, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline IPD readings (time frame: The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.