Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting for Endoscopy. Correlation of Symptoms With Upper GI Microbiome: The JUICE Study
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- The bacterial microbiome in patients with FD compared to control patients without upper GI symptoms and a normal endoscopy.
研究概览
简要总结
The purpose of this prospective cohort study is to compare upper GI symptoms and endoscopy findings in Canada with Japan and Iran, and correlate this with the upper GI microbiome. The investigators plan to recruit 500 new patients referred for upper GI endoscopy in Canada (McMaster University) and 500 in Japan (Tohoku University Hospital) and 500 from Iran (Tehran University of Medical Sciences). Written consent will be obtained from all participants. Patients will complete three symptom questionnaires and a demographic one before endoscopy. Then saliva collection device will be applied for collecting saliva and microbiota from the oral cavity. Esophagogastroduodenoscopy (EGD) will be performed thereafter and brushing of the esophagus, stomach, and the duodenum will be done using a sterile sheathed brush (one for each site) to sample collect gut microbiota and gastric biopsies will be done for assessing H.pylori status.
In addition, a group of these patients will undergo measurement of nitrate reductase activity (NRA) in their oral cavity. This will be done on twenty erosive gastro-esophageal reflux disease (GERD) patients, twenty non-erosive GERD patients, and twenty patients without any endoscopic or clinical GERD. This latter part of the study will be done at the Canadian and Iranian sites only. Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center. For specific substudies analysis of the mycome will also be carried out.
详细描述
Objective The purpose of the trial is to compare upper GI symptoms and endoscopy findings in Canada with Japan and Iran, and correlate this with the upper GI microbiome.
The primary outcomes is the bacterial microbiome in patients with FD compared to control patients without upper GI symptoms and a normal endoscopy. The investigators will do a planned subgroup analysis according to country of recruitment as well as sex and age based subgroups (<or =50 years versus >50 years)
Secondary outcomes are
- The microbiome in esophagitis patients compared to patients without esophagitis. To assess the oral nitrate reducing bacteria on the dorsum of the tongue of erosive GERD patients, patients with non-erosive GERD and comparing them with those of the normal controls enrolled in the JUICE study.
- The microbiome in H. pylori negative peptic ulcer disease (PUD) patients compared to H. pylori positive PUD patients and asymptomatic normal endoscopy controls.
- The microbiome in those with anxiety patients versus controls without anxiety in the FD group.
- The microbiome in those with depression versus controls without depression in the FD group.
- The microbiome in those with anxiety patients versus controls without anxiety in the patients without upper GI symptoms and a normal endoscopy.
- The microbiome in those with depression versus controls without depression in the patients without upper GI symptoms and a normal endoscopy
- Comparison of upper GI pathology (inflammation, dysplasia, malignancy) and the microbiome in the Canadian versus the Japanese populations.
Methodology Study population, inclusion & exclusion criteria This is a prospective international cohort study in Canada, Japan, and Iran. The investigators will recruit adult patients (≥18 years of age) who are undergoing esophago-gastro duodenoscopy (EGD) for any reason and are consenting to be enrolled in the study during the study period. The control group will be patients with no or minimal upper GI symptoms who are referred for EGD. Exclusion criteria will be the patients who cannot speak English in Canada, who cannot speak Japanese in Japan, and cannot speak Persian in Iran.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (≥18 years of age) who are undergoing esophago-gastro duodenoscopy (EGD) for any reason and are consenting to be enrolled in the study during the study period.
排除标准
- •the patients who cannot speak English in Canada, who cannot speak Japanese in Japan, and cannot speak Persian in Iran.
结局指标
主要结局
The bacterial microbiome in patients with FD compared to control patients without upper GI symptoms and a normal endoscopy.
时间窗: Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.
The primary outcomes is the bacterial microbiome in patients with FD compared to control patients without upper GI symptoms and a normal endoscopy. The investigators will do a planned subgroup analysis according to country of recruitment as well as sex and age based subgroups (\<or =50 years versus \>50 years). Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.
次要结局
- The microbiome in esophagitis patients compared to patients without esophagitis.(Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.)
- The microbiome in those with anxiety patients versus controls without anxiety in patients without upper GI symptoms and a normal endoscopy.(Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.)
- The microbiome in H. pylori negative peptic ulcer disease (PUD) patients compared to H. pylori positive PUD patients and asymptomatic normal endoscopy controls.(Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.)
- The microbiome in those with depression versus controls without depression in the patients without upper GI symptoms and a normal endoscopy(Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.)
- Comparison of upper GI pathology (inflammation, dysplasia, malignancy) and the microbiome in the Canadian versus the Japanese and the Iranian populations.(Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.)
- The microbiome in those with anxiety patients versus controls without anxiety in the FD group.(Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.)
- The microbiome in those with depression versus controls without depression in the FD group.(Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.)
研究者
Paul Moayyedi
Professor
Hamilton Health Sciences Corporation