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This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phototherapy | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Negative urease breath test at five weeks post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Side Effects | ||
| Negative urease breath test at 5 days post procedure | ||
| Reduction in acute post treatment bacterial population with respect to pretreatment samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconness Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| UMass Memorial Medical Center | Recruiting | Worcester | Massachusetts | 01655 | United States |
|
| Abbott Northwestern Hospital | Not yet recruiting | Minneapolis | Minnesota | 55430 | United States |
|
| D013272 | Stomach Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |