Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT03868267

Conditions

Functional Dyspepsia

Gastro Esophageal Reflux

Peptic Ulcer

Normal Control

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03868267

Start date

May 9, 2019

Status verified date

Feb, 2021

Completion date

Dec 1, 2023

Anticipated

Primary completion date

Aug 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Locations

Hamilton Health Science Centre

Recruiting

Hamilton, Ontario, Canada

Contacts

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Feb 9, 2021

Last verified

Feb, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2021-02-09.