- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00306280
Feasibility Study of Phototherapy System to Treat H Pylori
Phase 1 Study of Phototherapy System to Treat H Pylori
Study Overview
Detailed Description
H pylori causes almost all peptic ulcers and many gastric cancers and is widely prevalent worldwide. Treatment by multiple antibiotics and proton pump inhibitors is effective but are compromised today by significant non compliance due to side effects and duration of required treatment. Also, the increase in antibiotic resistance coupled with the decreased availability of new antibiotics project a significant population of patients who will not be treatable with antibiotics.
A special, visible-light based phototherapy system has been demonstrated to significantly decrease the viability of H pylori in vitro and in a brief clinical experiment.
This study will evaluate the safety and short term efficacy in up to 60 patients of the phototherapy system to treat H pylori.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconness Medical Center
-
Principal Investigator:
- Anthony Lembo
-
Contact:
- Anthony Lembo, MD
- Phone Number: 617-667-2138
- Email: alembo@bidmc.harvard.edu
-
Contact:
- Eoin Kelly, BS
- Phone Number: (617) 632 1108
- Email: eckelly@bidmc.harvard.edu
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Sub-Investigator:
- Sinil Sheth
-
Worcester, Massachusetts, United States, 01655
- Recruiting
- UMass Memorial Medical Center
-
Contact:
- David Cave
- Phone Number: 508-856-8399
- Email: drcave@pol.net
-
Contact:
- Ann Foley
- Phone Number: (508) 334-4098
- Email: foleya@ummhc.org
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Principal Investigator:
- David Cave
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55430
- Not yet recruiting
- Abbott Northwestern Hospital
-
Contact:
- Robert Ganz, MD
- Phone Number: 82941 612-871-1145
- Email: gastrodude@visi.com
-
Contact:
- Anne Hopper, BS
- Phone Number: (612) 870 5594
- Email: ahopper@mngastro.com
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Principal Investigator:
- Robert Ganz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 and < 90
- Documented positive for H. pylori infection by urease breath test, stool antigen or histology within thirty days prior to procedure
- Willing to comply with study requirements
- Able to undergo endoscopic esophagogastroduodenoscopy (EGD) with biopsy
Exclusion Criteria:
- History of gastric or duodenal carcinoma
- History of prior gastric or duodenal surgery
- Oral or intravenous antibiotics use within previous one month
- Use of bismuth subsalicylate (Pepto Bismol) within previous one month
- Use of photosensitizing drugs or nutritional supplements within previous one month
- Active peptic ulcer disease (gastric or duodenal ulcer)
- Esophagitis Grade II or higher
- Oral or intravenous antibiotics use within previous one month
- History of a bleeding disorder or anti-coagulant use that would prevent biopsy
- PPI treatment two weeks prior to the scheduled endoscopy
- Positive Pregnancy Test
- Known porphyria
- Suffer from phenylketonuria (PKU)
- Signs of jaundice
- Weight < 100 lb or > 250 lb
- Previously enrolled in this study
- Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of this study
- The subject is inappropriate for study participation, as determined by the Investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Negative urease breath test at five weeks post procedure
|
Secondary Outcome Measures
Outcome Measure |
---|
Procedural Side Effects
|
Negative urease breath test at 5 days post procedure
|
Reduction in acute post treatment bacterial population with respect to pretreatment samples
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- lmrx01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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