Clinical trial NCT00306280: Feasibility Study of Phototherapy System to Treat H Pylori
Official title: Phase 1 Study of Phototherapy System to Treat H Pylori
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori
Keywords: Helicobacter pylori
phototherapy
peptic ulcer
gastric cancer
Lead sponsor: LumeRx
Sponsor class: INDUSTRY
First posted: 2006-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Negative urease breath test at five weeks post procedure
Secondary outcomes:
measure: Procedural Side Effects
measure: Negative urease breath test at 5 days post procedure
measure: Reduction in acute post treatment bacterial population with respect to pretreatment samples
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
References: