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Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting

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ClinicalTrials.gov Identifier: NCT03868267
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
Tohoku University
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Paul Moayyedi, Hamilton Health Sciences Corporation

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.


Condition or disease
Functional Dyspepsia Gastro Esophageal Reflux Peptic Ulcer Normal Control

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting for Endoscopy. Correlation of Symptoms With Upper GI Microbiome: The JUICE Study
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy




Primary Outcome Measures :
  1. The bacterial microbiome in patients with FD compared to control patients without upper GI symptoms and a normal endoscopy. [ Time Frame: 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.


Secondary Outcome Measures :
  1. The microbiome in esophagitis patients compared to patients without esophagitis. [ Time Frame: Cross sectional data at time of endoscopy. Data will be accrued over a two year time period. ]
    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. 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.

  2. The microbiome in H. pylori negative peptic ulcer disease (PUD) patients compared to H. pylori positive PUD patients and asymptomatic normal endoscopy controls. [ Time Frame: Cross sectional data at time of endoscopy. Data will be accrued over a two year time period. ]
    Microbiome between H. pylori +ve and -ve peptic ulcer disease. 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.

  3. The microbiome in those with anxiety patients versus controls without anxiety in the FD group. [ Time Frame: 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. 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.

  4. The microbiome in those with depression versus controls without depression in the FD group. [ Time Frame: 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, 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.

  5. The microbiome in those with anxiety patients versus controls without anxiety in patients without upper GI symptoms and a normal endoscopy. [ Time Frame: Cross sectional data at time of endoscopy. Data will be accrued over a two year time period. ]
    microbiome in those with and without anxiety in those with normal EGD and no symptoms. 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.

  6. The microbiome in those with depression versus controls without depression in the patients without upper GI symptoms and a normal endoscopy [ Time Frame: Cross sectional data at time of endoscopy. Data will be accrued over a two year time period. ]
    microbiome in those with and without depression in those with normal EGD and no symptoms. 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.

  7. Comparison of upper GI pathology (inflammation, dysplasia, malignancy) and the microbiome in the Canadian versus the Japanese and the Iranian populations. [ Time Frame: 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. 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.


Biospecimen Retention:   Samples With DNA
Oral cavity, esophageal, gastric, and duodenal microbiota samples, as well as saliva for the NRA analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consenting patients will come to endoscopic unit of each hospital
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868267


Contacts
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Contact: Paul Moayyedi, MD,PhD,FRCP +1-905-521-2100 ext 76764 moayyep@mcmaster.ca
Contact: Takeshi Kanno, MD, PhD +1-289-684-4017 takeshi.kanno@medportal.ca

Locations
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Canada, Ontario
Hamilton Health Science Centre Recruiting
Hamilton, Ontario, Canada
Contact: Paul Moayyedi, MD,PhD,FRCP    +1-905-521-2100 ext 76764    moayyep@mcmaster.ca   
Contact: Takeshi Kanno, MD, PhD    +1-289-684-4017    takeshi.kanno@medportal.ca   
Iran, Islamic Republic of
Digestive Disease Research Institute, Tehran University of Medical Sciences Not yet recruiting
Tehran, Iran, Islamic Republic of, 14117
Contact: Siavosh Nasseri Moghaddam, MD, MPH    +98-912-148 1928    sianasseri@yahoo.com   
Contact: Takeshi Kanno, MD, PhD    +1-289-684 4017    takeshi.kanno@medportal.ca   
Japan
Tohoku University Hospital Not yet recruiting
Sendai, Miyagi, Japan, 9808574
Contact: Tomoyuki Koike, MD, PhD    +81-22-717-7171    tkoike@rd5.so-net.ne.jp   
Contact: Takeshi Kanno, MD, PhD    +1-289-684-4017    takeshi.kanno@medportal.ca   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Tohoku University
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Siavosh Nasseri-Moghaddam, MD, MPH Digestive Disease Research Institute, Tehran University of Medical Sciences
Study Director: 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

Additional Information:

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Responsible Party: Paul Moayyedi, Professor, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03868267     History of Changes
Other Study ID Numbers: 5278
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Moayyedi, Hamilton Health Sciences Corporation:
Quality of Life
Anxiety
Microbiome
Upper GI
Dyspepsia
Nitrates
Gastrointestinal symptoms
Additional relevant MeSH terms:
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Dyspepsia
Peptic Ulcer
Gastroesophageal Reflux
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases