Phase 1 Study of Phototherapy System to Treat H Pylori
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Negative urease breath test at five weeks post procedure
研究概览
简要总结
This purpose of this study is to determine whether phototherapy can be used to safely and effectively treat H pylori.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Negative urease breath test at five weeks post procedure
次要结局
- Procedural Side Effects
- Negative urease breath test at 5 days post procedure
- Reduction in acute post treatment bacterial population with respect to pretreatment samples