Crohn Disease Clinical Trial
Official title:
Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe
Verified date | May 2024 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability
Status | Active, not recruiting |
Enrollment | 5 |
Est. completion date | April 30, 2027 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours. | |
Primary | IPD readings after Glucose/Galactose infusion | the IPD probe's ability to measure a more positive reading when Glucose or Galactose have been perfused. | The outcome measure is actively recorded in real-time during the procedure, an average of 3 hours. | |
Primary | 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. | Imaging data is collected during the procedure, and analyzed within 1 year of collection. |
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