Feasibility Study of Phototherapy System to Treat H Pylori
Recruitment status was Recruiting
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Purpose
This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
| Condition | Intervention |
|---|---|
|
Helicobacter Pylori |
Device: Phototherapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1 Study of Phototherapy System to Treat H Pylori |
- Negative urease breath test at five weeks post procedure
- Procedural Side Effects
- Negative urease breath test at 5 days post procedure
- Reduction in acute post treatment bacterial population with respect to pretreatment samples
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | March 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconness Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Anthony Lembo, MD 617-667-2138 alembo@bidmc.harvard.edu | |
| Contact: Eoin Kelly, BS (617) 632 1108 eckelly@bidmc.harvard.edu | |
| Principal Investigator: Anthony Lembo | |
| Sub-Investigator: Sinil Sheth | |
| UMass Memorial Medical Center | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| Contact: David Cave 508-856-8399 drcave@pol.net | |
| Contact: Ann Foley (508) 334-4098 foleya@ummhc.org | |
| Principal Investigator: David Cave | |
| United States, Minnesota | |
| Abbott Northwestern Hospital | Not yet recruiting |
| Minneapolis, Minnesota, United States, 55430 | |
| Contact: Robert Ganz, MD 612-871-1145 ext 82941 gastrodude@visi.com | |
| Contact: Anne Hopper, BS (612) 870 5594 ahopper@mngastro.com | |
| Principal Investigator: Robert Ganz | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00306280 History of Changes |
| Other Study ID Numbers: | lmrx01 |
| Study First Received: | March 21, 2006 |
| Last Updated: | September 19, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by LumeRx:
|
Helicobacter pylori phototherapy peptic ulcer gastric cancer |
ClinicalTrials.gov processed this record on May 16, 2013