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Feasibility Study of Phototherapy System to Treat H Pylori

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00306280
Recruitment Status : Unknown
Verified September 2006 by LumeRx.
Recruitment status was:  Recruiting
First Posted : March 23, 2006
Last Update Posted : September 20, 2006
Information provided by:

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

Condition or disease Intervention/treatment
Helicobacter Pylori Device: Phototherapy

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Phototherapy System to Treat H Pylori
Study Start Date : March 2006
Estimated Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Negative urease breath test at five weeks post procedure

Secondary Outcome Measures :
  1. Procedural Side Effects
  2. Negative urease breath test at 5 days post procedure
  3. Reduction in acute post treatment bacterial population with respect to pretreatment samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306280

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         
Sponsors and Collaborators

ClinicalTrials.gov Identifier: NCT00306280     History of Changes
Other Study ID Numbers: lmrx01
First Posted: March 23, 2006    Key Record Dates
Last Update Posted: September 20, 2006
Last Verified: September 2006

Keywords provided by LumeRx:
Helicobacter pylori
peptic ulcer
gastric cancer