Recruiting

Phototherapy

Sponsor:

LumeRx

Code:

NCT00306280

Conditions

Helicobacter Pylori

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Phototherapy

Study Details

Brief summary:

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

Conditions

Helicobacter Pylori

Study ID

NCT00306280

Start date

Mar, 2006

Status verified date

Sep, 2006

Completion date

Mar, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Phototherapy

Primary outcome measure

  • Negative urease breath test at five weeks post procedure [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Beth Israel Deaconness Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Anthony Lembo, MD

617-667-2138alembo@bidmc.harvard.edu

Eoin Kelly, BS

(617) 632 1108eckelly@bidmc.harvard.edu

Principal Investigator:

Anthony Lembo

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

David Cave

508-856-8399drcave@pol.net

Ann Foley

(508) 334-4098foleya@ummhc.org

Principal Investigator:

David Cave

More Information

Sponsor

LumeRx

Last update posted

Sep 20, 2006

Last verified

Sep, 2006

Keywords

  • Helicobacter pylori
  • phototherapy
  • peptic ulcer
  • gastric cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LumeRx on 2006-09-20.