Helicobacter PyloriNCT00306280
Feasibility Study of Phototherapy System to Treat H Pylori
A study testing Phototherapy in people with Helicobacter Pylori, run by LumeRx at 3 sites in United States.
Trial summary
This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Phototherapy
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02215
Anthony Lembo, MD, 617-667-2138, alembo@bidmc.harvard.edu
Eoin Kelly, BS, (617) 632 1108, eckelly@bidmc.harvard.edu
- Not yet recruiting
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55430
Robert Ganz, MD, 612-871-1145 ext. 82941, gastrodude@visi.com
Anne Hopper, BS, (612) 870 5594, ahopper@mngastro.com
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
David Cave, 508-856-8399, drcave@pol.net
Ann Foley, (508) 334-4098, foleya@ummhc.org
About this study
Official title: Phase 1 Study of Phototherapy System to Treat H Pylori
This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
Read the 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.
- Conditions
- Helicobacter Pylori
- Being tested
- Phototherapy
- Keywords
- Helicobacter pylori, phototherapy, peptic ulcer, gastric cancer
- Medical subject headings
- Peptic Ulcer, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startMar 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- LumeRx
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306280
- Sponsor's protocol ID
- lmrx01
- Status last verified
- Sep 2006
- First submitted
- 21 Mar 2006
- Last updated
- 20 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Phototherapy System to Treat H Pylori
- ClinicalTrials.gov ID
- NCT00306280
- Acronym / sponsor ID
- lmrx01
- Conditions
- Helicobacter Pylori
- Keywords
- Helicobacter pylori, phototherapy, peptic ulcer, gastric cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- LumeRxIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Mar 2007
- First posted
- 23 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phototherapy | Device | – |
Primary outcome
Negative urease breath test at five weeks post procedure
3 secondary outcomes
Procedural Side Effects
Negative urease breath test at 5 days post procedure
Reduction in acute post treatment bacterial population with respect to pretreatment samples
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy in people with Helicobacter Pylori, run by LumeRx at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative urease breath test at five weeks post procedure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2006.