ClinicalTrials.gov
Cure8 trial brief
Why This Matters
A minimally invasive probe that measures intestinal potential difference in real time could provide a localized, objective way to study gut barrier function—an important feature in Crohn’s disease and other IBDs. Validating such a tool may improve research and, eventually, clinical assessment of mucosal permeability.
Because this is a feasibility study in healthy volunteers, it’s an early step toward tools that might later be tested in people with IBD.
Who Should Pay Attention
Clinicians and researchers working on intestinal permeability or IBD diagnostics; device developers; patients interested in research advances in gut barrier testing.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment15 participants
Study statusActive_not_recruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes an interventional feasibility study testing a trans-nasal intestinal potential difference (IPD) probe developed to measure gut mucosal permeability in real time.
The device is passed through the nose into the small intestine, uses ionic perfusion and voltage measurements to assess IPD, and acquires M-mode OCT images to confirm tissue contact and provide imaging during the procedure.
The trial plans to enroll healthy adult volunteers and records baseline and post-infusion IPD readings and image quality as primary feasibility outcomes.
The study frames increased intestinal permeability (“leaky gut”) as relevant to Crohn’s disease, IBD, celiac disease, and environmental enteropathy, and positions the IPD probe as an alternative to sugar-ratio tests with potential for localized, real-time assessment.
Eligibility excludes people with recent antibiotics, certain infections, upper GI/respiratory anatomical issues, bleeding risk, and other conditions that could complicate the procedure.
This is a methods/feasibility trial rather than a therapeutic trial; it aims to test whether the device can safely and accurately record voltages and images, not to evaluate treatment effects. The registered status is ACTIVE_NOT_RECRUITING and planned enrollment is small (15), focused on healthy volunteers.
Keep In Mind
This is a registered interventional feasibility study (ClinicalTrials.gov record) with planned enrollment of ~15 healthy adults and status ACTIVE_NOT_RECRUITING. It tests device feasibility and imaging/measurement quality and does not provide clinical results or validation in patients with active disease.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorMassachusetts General Hospital
Trial IDNCT04565821
Study typeInterventional
Trial phaseNA
Enrollment15 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 2, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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