Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting

NCT03868267 | Unknown

• 1 other identifier: 5278
• Study Type: observational
• Target: 1,500
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Quality of Life; Anxiety; Microbiome; Upper GI; Dyspepsia; Nitrates; Gastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

• The bacterial microbiome in patients with FD compared to control patients without upper GI symptoms and a normal endoscopy.

  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.

  Cross sectional data at time of endoscopy. Data will be accrued over a two year time period.

Secondary Outcomes (7)

• 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 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 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.

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting patients will come to endoscopic unit of each hospital

You may qualify if:

• 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.

You may not qualify if:

• the patients who cannot speak English in Canada, who cannot speak Japanese in Japan, and cannot speak Persian in Iran.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Tohoku University: collaborator
• Tehran University of Medical Sciences: collaborator

Study Sites (3)

Hamilton Health Science Centre

Hamilton, Ontario, Canada

RECRUITING

Digestive Disease Research Institute, Tehran University of Medical Sciences

Tehran, 14117, Iran

NOT YET RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 9808574, Japan

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Oral cavity, esophageal, gastric, and duodenal microbiota samples, as well as saliva for the NRA analysis.

MeSH Terms

Conditions

Gastroesophageal Reflux; Peptic Ulcer; Anxiety Disorders; Dyspepsia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Siavosh Nasseri-Moghaddam, MD, MPH

  Digestive Disease Research Institute, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Reza Malekzadeh, MD

  Digestive Disease Research Institute, Tehran University of Medical Sciences

  STUDY DIRECTOR

• Tomoyuki Koike, MD, PhD

  Division of Gastroenterology, Tohoku University Graduate school of Medicine

  STUDY DIRECTOR

• Atsushi Masamune, MD, PhD

  Division of Gastroenterology, Tohoku University Graduate school of Medicine

  STUDY DIRECTOR

Central Study Contacts

Paul Moayyedi, MD,PhD,FRCP

CONTACT

+1-905-521-2100; moayyep@mcmaster.ca

Takeshi Kanno, MD, PhD

CONTACT

+1-289-684-4017; takeshi.kanno@medportal.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: March 11, 2019
• Study Start: May 9, 2019
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

CA (1); IR (1); JP (1)