Feasibility Study of Phototherapy System to Treat H Pylori

Helicobacter Pylori Clinical Trial

Official title:

Phase 1 Study of Phototherapy System to Treat H Pylori

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00306280
• Other study ID #: lmrx01
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2006
• Last updated: September 19, 2006
• Start date: March 2006
• Est. completion date: March 2007

Study information

• Verified date: September 2006
• Source: LumeRx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Helicobacter Pylori

Intervention

Device:
• Phototherapy

Locations

Country	Name	City	State
United States	Beth Israel Deaconness Medical Center	Boston	Massachusetts
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
LumeRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative urease breath test at five weeks post procedure
Secondary	Procedural Side Effects
Secondary	Negative urease breath test at 5 days post procedure
Secondary	Reduction in acute post treatment bacterial population with respect to pretreatment samples