The Bacterial Composition of the Stomach in Reflux Disease

Active, not recruiting

• Conditions: GORD; Oesophageal Cancer; Oesophageal Carcinoma; Oesophageal Reflux; Barrett Esophagus; Esophagitis; Gastric Cancer; Gastro Esophageal Reflux
• Interventions: Diagnostic Test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes

• Registration Number: NCT03835663
• Lead Sponsor: Imperial College London

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-04
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Patients who have upper GI malignancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Difference in the bacterial composition of the gastric mucosa between the three groups	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.
Difference in the amount of bacteria of the gastric mucosa between the three previously described groups.	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.

Trial Locations

Locations (1)

Imperial College Healthcare, St Mary's Hospital, Paddington; 🇬🇧 London, United Kingdom