Fecal Auto-transplantation for Enteric Microbial Rehabilitation Post 14 Day Antibiotics Therapy Against Helicobacter Pylori Infection
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessing restoration of the fecal microbiota after 14 day of H. pylori antibiotic regimen
研究概览
简要总结
Current guidelines mandate Helicobacter pylori (H. Pylori) eradication with 2-3 antibiotics for 14 days ,This may result in multiple side effects and in eradication of important bacterial species to human health, exposing humans to multiple disease conditions.
Preservation of fecal microbiome prior to antibiotic therapy and auto-transplantation of the microbes post H. pylori eradication, will enable avoiding eradication of beneficial microbial populations and perhaps protect from consequent disease conditions.
详细描述
This is a pilot study. Prior to antibiotics therapy for their baseline H.Pylori infection, patients will be asked to deliver at least 50 grams of fresh stool to the Tel Aviv Medical Center (TLVMC) Bacteriotherapy Clinic. All patients will receive therapy to eradicate H. Pylori according to current guidelines (14 days) and physician's discretion, and will be tested to validate H. pylori eradication, at least 21 days post therapy (according to guidelines: Kyoto/ ACG/ Maastricht). For patients that H. pylori was not eradicated- a second line therapy will be administered according to guidelines, and stool will be retrieved at an additional time point, before FMT and after successful H. pylori eradication.
Patients will be allocated into one of three groups:
- Intervention group- patients will undergo Auto-FMT through capsules.
- Intervention group-patients will undergo Auto-FMT through enema.
- Control Group-patients will receive FMT through placebo capsules.
Patients in Intervention group will undergo an additional breath test for H. Pylori, 14-28 days post FMT, to exclude H. pylori-self infection, by the FMT. This concern is related to the capsules therapy, although the fecal filtrate is double packaged in two capsules (one inside another) which are designed to dissolve only in the duodenum at a basic pH.
If patients are found to be re-infected, they will undergo an additional antibiotics course and post eradication will receive FMT through an enema according to the above specified protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Capsules will be either with FMT or placebo. Same appearance. Patients will be randomized to either arm.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old
- •Positive H. pylori on either breath test or gastric biopsy
- •Patient is intended to receive antibiotics therapy for H. pylori eradication
排除标准
- •Severe systemic disease that may impact the microbiome. For example: heart disease, type two diabetes, chronic liver or kidney failure
- •Antibiotics therapy during the prior 2 months to enrollment
- •Planned to receive antibiotics within the upcoming 2 months (surgery etc) for reasons other than H. Pylori
- •Inability to complete the study protocol (swallow capsules or to hold enema content for at least 15 minutes)
- •Pregnancy
- •Inability to give informed consent
结局指标
主要结局
Assessing restoration of the fecal microbiota after 14 day of H. pylori antibiotic regimen
时间窗: 4 weeks
A change of \<10% of fecal microbial diversity before antibiotics and after FMT
次要结局
- Fecal microbial diversity change in auto-FMT delivered through capsules 18 weeks post FMT compared to 4 weeks post FMT(18 weeks)
- Side effects rate of auto-FMT delivered through enema(4 months)
- Fecal microbial diversity change in auto-FMT delivered through enema 18 weeks post FMT compared to 4 weeks post FMT(18 weeks)
- Side effects rate of auto-FMT delivered through capsules(4 months)
- H pylori re-infection rate after auto-FMT procedure(4 weeks)
研究者
Shmuel Kivity, MD
director, R&D department
Tel-Aviv Sourasky Medical Center