NCT00306280

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 20, 2006

Status Verified

September 1, 2006

First QC Date

March 21, 2006

Last Update Submit

September 19, 2006

Conditions

Helicobacter Pylori

Keywords

Helicobacter pyloriphototherapypeptic ulcergastric cancer

Outcome Measures

Primary Outcomes (1)

  • Negative urease breath test at five weeks post procedure

Secondary Outcomes (3)

  • Procedural Side Effects

  • Negative urease breath test at 5 days post procedure

  • Reduction in acute post treatment bacterial population with respect to pretreatment samples

Interventions

PhototherapyDEVICE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Israel Deaconness Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55430, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Peptic UlcerStomach Neoplasms

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 23, 2006

Study Start

March 1, 2006

Study Completion

March 1, 2007

Last Updated

September 20, 2006

Record last verified: 2006-09

Locations

US(3)