The Bacterial Composition of the Stomach in Reflux Disease

Imperial College London

Status: Active, not recruiting

Conditions: Oesophageal Reflux; Esophagitis; Oesophageal Cancer; GORD; Gastric Cancer; Oesophageal Carcinoma; Gastro Esophageal Reflux; Barrett Esophagus

Treatments: Diagnostic Test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes

Study type: Observational

Funder types: Other

Identifiers

NCT03835663

R18055

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Patients with non erosive reflux

Description:

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

Treatment:

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

Patients with erosive reflux

Description:

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

Treatment:

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

Patients with no reflux

Description:

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

Treatment:

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