OCT-Guided Trans Nasal Imaging for Environmental Enteric Dysfunction

Overseen By Anita Chung, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Anticoagulants, Antiplatelets, NSAIDs, Steroids

Disqualifiers: Upper respiratory disease, Upper GI surgery, High-risk pregnancy, Diabetes, 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 explores a new imaging tool called the TNIB catheter, designed to improve the diagnosis of digestive system diseases. The goal is to determine if this device can safely and effectively capture detailed images of the intestines. Healthy adults and healthy pregnant women in their second trimester are invited to participate. Participants should have no history of respiratory or gastrointestinal surgeries and must be able to fast before the procedure. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diagnostic techniques for digestive diseases.

Do I need to stop taking my current medications to join the trial?

Yes, you may need to stop taking certain medications. The trial excludes people on medications that delay stomach emptying, drugs that affect blood clotting, and nasal or allergy steroids.

What prior data suggests that this imaging device is safe for use in humans?

Research has shown that the TNIB catheter is a new tool being tested to capture detailed images inside the intestines. Currently, specific safety information from other studies using this device is unavailable. Since this clinical trial is in the "Not Applicable" phase, the focus is on understanding how the device functions rather than assessing safety issues. This phase typically indicates that the device is not expected to cause harm.

If the TNIB catheter were unsafe, it likely wouldn't have reached this stage of testing. Although direct evidence about the safety of this imaging device is lacking, testing on healthy adults and pregnant women suggests it is considered low risk. However, as with any medical study, unexpected side effects may occur, so researchers will closely monitor participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TNIB catheter is unique because it uses optical coherence tomography (OCT) to obtain detailed microscopic images of the intestine through a transnasal approach. Unlike traditional methods for diagnosing environmental enteric dysfunction, which often rely on invasive endoscopies, this technique offers a less invasive way to visualize the gut lining. Researchers are excited about this method because it could provide real-time, high-resolution images, potentially leading to quicker and more accurate assessments of intestinal health, especially in sensitive populations like healthy pregnant women.

What evidence suggests that this imaging device is effective for gastrointestinal diagnostics?

Research has shown that environmental enteric dysfunction (EED) links to issues like poor growth and malnutrition. This trial studies the TNIB catheter to determine if it can help doctors diagnose gut diseases, including EED, more effectively. Although new, this device could provide clear images of the intestine, aiding doctors in identifying issues more accurately. Early signs suggest that better diagnosis of EED might help address related health problems like stunted growth and poor vaccine response. While still under testing, this imaging tool aims to simplify the identification and understanding of these gut problems. ^{2 5 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 study is looking for healthy adults aged 18-60 and pregnant women in their second trimester, without high-risk conditions or diabetes on medication. Participants must be able to consent and fast before the procedure. Those with nasal, gastrointestinal, or clotting issues, or using certain medications are excluded.

Inclusion Criteria

I am in my second trimester of pregnancy.

Healthy subjects

Subject must fast (no solid food) for at least 8 hours and have no liquids within 2 hours prior to the procedure

Exclusion Criteria

I have had surgery on my upper stomach or intestines.

I am pregnant with diabetes and need medication to manage it.

Pregnant women with high-risk pregnancies such as history of hyperemesis gravidarum, HIV, severe anemia or any other high-risk pregnancy conditions at the discretion of the subject's physician and the PI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo imaging of the upper gastrointestinal tract using the TNIB device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging procedure

6 months

What Are the Treatments Tested in This Trial?

Interventions

• TNIB Catheter

Trial Overview The trial is testing a new TNIB Catheter imaging device developed by the Tearney Laboratory to enhance diagnosis of gastrointestinal diseases. It involves trans nasal imaging of the small intestine using this novel catheter.

How Is the Trial Designed?

Group I: Feasibility of TNIB catheter Experimental Treatment 1 Intervention

The feasibility of using the TNIB catheter to obtain microscopic images of the intestine. Healthy adult participants, and healthy pregnant women in their 2nd trimester of pregnancy will be enrolled, and their upper gastrointestinal tract will be imaged by the TNIB device

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6876067/

Environmental enteric dysfunction: a review of potential ... EED has been associated with poor outcomes, including chronic malnutrition (stunting), wasting and reduced vaccine efficacy among children ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916525003223

Biomarkers of environmental enteric dysfunction and ... Biomarkers of environmental enteric dysfunction and neurodevelopmental outcomes among children in rural Bangladesh and Kenya: a prospective cohort study. Author ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11167436/

Machine-learning-based integrative –'omics analyses reveal ... Machine-learning-based integrative –'omics analyses reveal immunologic and metabolic dysregulation in environmental enteric dysfunction.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1097%2FMPG.0000000000001978

Markers of Environmental Enteric Dysfunction Are ... In this study designed to evaluate the relationship between novel biomarkers of EED, nutritional and inflammatory biomarkers, with ...

5. cell.com cell.com/cell-reports-medicine/fulltext/S2666-3791(24)00352-5

Protection from environmental enteric dysfunction and ... Severe EED results in linear growth stunting, slowed neurocognitive development, and unresponsiveness to oral vaccines. Prenatal exposure to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5964017/

Markers of environmental enteric dysfunction are associated ... In this study designed to evaluate the relationship between novel biomarkers of EED, nutritional and inflammatory biomarkers, with neurodevelopmental outcomes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4472379/

Environmental enteric dysfunction: An overview - PMC Environmental enteric dysfunction (EED) refers to an incompletely defined syndrome of inflammation, reduced absorptive capacity, and reduced barrier function ...

8. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-019-1417-3

Environmental enteric dysfunction: a review of potential ... Five highly interdependent mechanisms may link EED to poor health outcomes: 1) increased intestinal permeability with translocation of bacteria ...