The Bacterial Composition of the Stomach in Reflux Disease

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03835663
• Other study ID #: R18055
• Status: Active, not recruiting
• Start date: June 4, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Neoplasms
• Esophagitis
• Gastric Cancer
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• GORD
• Oesophageal Cancer
• Oesophageal Carcinoma
• Oesophageal Reflux
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare, St Mary's Hospital, Paddington	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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