Feasibility Study of Phototherapy System to Treat H Pylori

LumeRx

Status

Unknown

Conditions

Helicobacter Pylori

Treatments

Device: Phototherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00306280

lmrx01

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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