Skip to content

The Bacterial Composition of the Stomach in Reflux Disease

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03835663
Enrollment
100
Registered
2019-02-08
Start date
2018-06-04
Completion date
2024-12-31
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTNo intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes

Standard upper GI endoscopy with biopsies

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in the bacterial composition of the gastric mucosa between the three groupsSamples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80CBacterias 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 -80CBacterias found in the gastric mucosa will be quantified and compared within the three groups.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026