Know Cancer

forgot password

Phase 1 Study of Phototherapy System to Treat H Pylori

18 Years
90 Years
Open (Enrolling)
Helicobacter Pylori

Thank you

Trial Information

Phase 1 Study of Phototherapy System to 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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Negative urease breath test at five weeks post procedure


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

March 2007

Related Keywords:

  • Helicobacter Pylori
  • Helicobacter pylori
  • phototherapy
  • peptic ulcer
  • gastric cancer



Beth Israel Deaconness Medical Center Boston, Massachusetts  02215
UMass Memorial Medical Center Worcester, Massachusetts  01655
Abbott Northwestern Hospital Minneapolis, Minnesota  55430