IPD Probe for Gut Permeability

Overseen By Anna Gao, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Anticoagulants, NSAIDs, Antibiotics, others

Disqualifiers: Respiratory disease, Gastrointestinal surgery, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the IPD probe, gently inserted through the nose, can effectively measure gut permeability. It functions like a check on the gut barrier, ensuring it works properly. The trial seeks healthy volunteers willing to avoid solid food for 8 hours before the procedure and who do not have major nasal or gut issues. Those with a history of respiratory problems, surgeries, or certain daily medications may not qualify. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on gut health.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as those that delay gastric emptying, impair clotting, nasal steroids, antibiotics, H2 Histamine Antagonists, and Mast Cell stabilizers. If you are on any of these, you would need to stop them to participate.

What prior data suggests that this IPD probe is safe for measuring gut permeability?

Research has shown that the IPD probe, used through the nose, is designed to be minimally invasive, reducing the likelihood of harm or serious discomfort. Although studies have not provided detailed safety information for this specific device, its minimally invasive nature suggests it might be comfortable for users. The probe's small diameter of 1.2 mm helps minimize potential discomfort. As this is a feasibility study, researchers are still assessing the probe's practicality and safety. Prospective participants should know that this type of study is often an initial step in testing a new tool, focusing on its safety and ease of use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IPD Probe for gut permeability because it offers a new, non-invasive method to measure gut health. Unlike traditional methods, which often involve complex and invasive procedures, this probe is administered trans-nasally, making it less intrusive and potentially more comfortable for patients. The hope is that this approach will provide more accurate and immediate insights into gut permeability, paving the way for better diagnoses and treatments in gastrointestinal health.

What evidence suggests that the IPD probe is effective for measuring gut permeability?

Research has shown that the IPD Probe using TNIT effectively assesses gut barrier function. This trial will explore the feasibility of using a trans-nasal IPD probe to measure gut permeability. The tool is user-friendly and quickly indicates how substances pass through the gut wall. It measures gut potential difference (GPD), which is crucial for understanding gut health. Studies have found this method practical and comfortable for patients with conditions such as leaky gut and certain inflammatory diseases. Overall, existing evidence supports the probe's effectiveness in evaluating gut health in these conditions. ^{2 3 6 7 8}

Who Is on the Research Team?

Guillermo Tearney, M.D, PhD.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-60 who can consent and fast for at least 8 hours. It's not suitable for those with respiratory diseases, nasal steroid use, gastric emptying delays, alcoholism, certain medication uses (like clotting impairments or mast cell stabilizers), recent antibiotics use, liver diseases, galactosemia, uncontrolled diabetes, lactation due to pregnancy or any contraindications to nasopharyngeal procedures.

Inclusion Criteria

Subject must fast (no solid food) for at least 8 hours prior to the procedure

I can understand and agree to the treatment plan.

People who are in good health and do not have any medical conditions.

Exclusion Criteria

I have been diagnosed with or suspected to have Galactosemia.

I am on medication that slows down my stomach emptying.

I am currently taking medication for heartburn or ulcers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo the trans-nasal IPD probe procedure to measure intestinal potential difference and image quality

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IPD Probe via TNIT

Trial Overview The study is testing the feasibility of a trans-nasal IPD probe as a tool to measure gut permeability. Participants will undergo this minimally invasive procedure where the probe is inserted through the nose to assess intestinal function.

How Is the Trial Designed?

Group I: Feasibility of trans-nasal IPD probe Experimental Treatment 1 Intervention

The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. withpower.com withpower.com/trial/ipd-probe-for-gut-permeability-3b899

IPD Probe for Gut Permeability · Info for Participants ... IPD Probe via TNIT will have tolerable side effects & efficacy for patients with Environmental Enteropathy, Increased Permeability, Inflammatory Diseases ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9648666/

Minimally Invasive Image-Guided Gut Transport Function ... We demonstrate a minimally invasive probe for real-time localized gut permeability evaluation through gut potential difference (GPD) measurement.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/88/NCT05857488/Prot_SAP_000.pdf

PROTOCOL ... IPD measurements is confirmed via OCT imaging, the optical probe will be removed from the TNIT. To create a reference potential for IPD measurements, the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9541095/

Passively scanned, single‐fiber optical coherence ... The brush was introduced into the GI tract via the TNIT device in the same manner as the IPD device. The addition of the M‐mode OCT probe to the brush helped to ...

5. clinicaltrial.be clinicaltrial.be/nl/details/52250?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Feasibility Study to Assess a Trans-nasal Intestinal Pote... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04565821

Feasibility Study to Assess a Trans-nasal Intestinal ... 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 ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lsm.23576

Passively scanned, single‐fiber optical coherence ... The IPD device, with an outer diameter (OD) of 1.2 mm and a length of 1.2 m (Figure 1A), measures transepithelial voltage as a proxy of small ...

8. mdpi.com mdpi.com/1424-8220/12/10/13002

The Detection of Patients at Risk of Gastrointestinal Toxicity ... It is well known that the electronic nose can be used to identify differences between human health and disease for a range of disorders.