The Bacterial Composition of the Stomach in Reflux Disease

NCT ID: NCT03835663

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-04

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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GORD Oesophageal Cancer Oesophageal Reflux Gastric Cancer Gastro Esophageal Reflux Oesophageal Carcinoma Barrett Esophagus Esophagitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with non erosive reflux

Patients with symptoms of reflux but no evidence of oesophagitis or Barretts oesophagus on endoscopy.

No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes

Intervention Type DIAGNOSTIC_TEST

Standard upper GI endoscopy with biopsies

Patients with erosive reflux

Patients with symptoms of reflux with evidence of oesophagitis or Barretts oesophagus on endoscopy.

No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes

Intervention Type DIAGNOSTIC_TEST

Standard upper GI endoscopy with biopsies

Patients with no reflux

Patients with healthy oesophago-gastric mucosa and no symptoms of reflux.

No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes

Intervention Type DIAGNOSTIC_TEST

Standard upper GI endoscopy with biopsies

Interventions

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No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes

Standard upper GI endoscopy with biopsies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Imperial College Healthcare, St Mary's Hospital, Paddington

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R18055

Identifier Type: -

Identifier Source: org_study_id

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