The Bacterial Composition of the Stomach in Reflux Disease

NCT03835663 | Active Not Recruiting

• 1 other identifier: R18055
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Difference in the bacterial composition of the gastric mucosa between the three groups

  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.

  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

Study Arms (3)

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

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

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

Interventions

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

Standard upper GI endoscopy with biopsies

Patients with erosive reflux; Patients with no reflux; Patients with non erosive reflux

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who have upper GI malignancy

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare, St Mary's Hospital, Paddington

London, W2 1NY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Endoscopic biopsy from gastric mucosa Saliva Liquid gastric content

MeSH Terms

Conditions

Esophageal Neoplasms; Gastroesophageal Reflux; Stomach Neoplasms; Barrett Esophagus; Esophagitis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Stomach Diseases; Precancerous Conditions; Gastroenteritis

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 8, 2019
• Study Start: June 4, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)