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Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting

NCT03868267 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2021-02-09

No results posted yet for this study

Summary

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.

Conditions

  • Functional Dyspepsia
  • Gastro Esophageal Reflux
  • Peptic Ulcer
  • Normal Control

Sponsors & Collaborators

  • Tohoku University

    collaborator OTHER

  • Tehran University of Medical Sciences

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Siavosh Nasseri-Moghaddam, MD, MPH · Digestive Disease Research Institute, Tehran University of Medical Sciences

  • Reza Malekzadeh, MD · Digestive Disease Research Institute, Tehran University of Medical Sciences

  • Tomoyuki Koike, MD, PhD · Division of Gastroenterology, Tohoku University Graduate school of Medicine

  • Atsushi Masamune, MD, PhD · Division of Gastroenterology, Tohoku University Graduate school of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2022-08-01
Completion
2023-12-01

Countries

  • Canada
  • Iran
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868267 on ClinicalTrials.gov