The Bacterial Composition of the Stomach in Reflux Disease

March 25, 2024 updated by: Imperial College London

Identification of Bacteria Responsible for the the Development of Oesophago-gastric Cancer

Gastric and oesophageal (OG) cancer associated with poor long term outcome as overall less than 25% of patients survive for more than 5 years due to late recognition of the disease. Growing evidence suggests an important role for bacteria in OG cancer and gastro esophageal reflux disease (GORD) development. About 1 in 10 people suffer from GORD and this one of the most common conditions leading to gastric and oesophageal cancer.

In GORD surgical therapy is the most successful preventing cancer but around 85% of patient experience complications afterwards. Acid suppressing medications are reducing the risk of oesophageal cancer but equally increasing the risk of gastric cancer. They also shorten patients' life expectancy and often fail to provide relief. Analysis of stool samples of patients with GORD demonstrated different gut bacterial compositions to normal and rather resembled the one found in cancer.

There is a clear need to improve the outcome of OG cancer. This could be achieved by identifying bacteria responsible for cancer development in gastric tissue, gastric content and saliva and potentially eliminate them hence avoid the development of cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare, St Mary's Hospital, Paddington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with erosive, non-erosive reflux and patients with no symptoms of reflux and healthy upper GI mucosa.

Description

Inclusion Criteria:

  • Patients who deemed necessary for an upper gastro intestinal endoscopy for clinical reasons and consent for additional gastric mucosal biopsies for study purposes

Exclusion Criteria:

  • Patients who have upper GI malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with non erosive reflux
Patients with symptoms of reflux but no evidence of oesophagitis or Barretts oesophagus on endoscopy.
Diagnostic test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes
Standard upper GI endoscopy with biopsies
Patients with erosive reflux
Patients with symptoms of reflux with evidence of oesophagitis or Barretts oesophagus on endoscopy.
Diagnostic test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes
Standard upper GI endoscopy with biopsies
Patients with no reflux
Patients with healthy oesophago-gastric mucosa and no symptoms of reflux.
Diagnostic test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes
Standard upper GI endoscopy with biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in the bacterial composition of the gastric mucosa between the three groups
Time Frame: Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C
Bacterias found in the stomach will be identified with 16s RNA analysis. The type of bacterias identified will be compared between the three groups.
Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C
Difference in the amount of bacteria of the gastric mucosa between the three previously described groups.
Time Frame: Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C
Bacterias found in the gastric mucosa will be quantified and compared within the three groups.
Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (Actual)

February 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R18055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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