GORDNCT03835663
The Bacterial Composition of the Stomach in Reflux Disease
An observational study of GORD and Oesophageal Cancer, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GORD, Oesophageal Cancer, Oesophageal Reflux
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with erosive, non-erosive reflux and patients with no symptoms of reflux and healthy upper GI mucosa.
Who may be able to join
- Patients who deemed necessary for an upper gastro intestinal endoscopy for clinical reasons and consent for additional gastric mucosal biopsies for study purposes
Who cannot join
- Patients who have upper GI malignancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare, St Mary's Hospital, Paddington
London, W2 1NY
About this study
Official title: Identification of Bacteria Responsible for the the Development of Oesophago-gastric Cancer
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
- Being tested
- No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes
- Medical subject headings
- Esophageal Neoplasms, Gastroesophageal Reflux, Stomach Neoplasms, Barrett Esophagus, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposesDiagnostic test
Standard upper GI endoscopy with biopsies
| Study group | Role | What they receive |
|---|---|---|
| Patients with non erosive reflux | Patients with symptoms of reflux but no evidence of oesophagitis or Barretts oesophagus on endoscopy. Receives: 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. Receives: 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. Receives: Diagnostic Test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start4 Jun 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GORDStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835663
- Sponsor's protocol ID
- R18055
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2019
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Bacteria Responsible for the the Development of Oesophago-gastric Cancer
- ClinicalTrials.gov ID
- NCT03835663
- Acronym / sponsor ID
- R18055
- Conditions
- GORD, Oesophageal Cancer, Oesophageal Reflux, Gastric Cancer, Gastro Esophageal Reflux, Oesophageal Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with non erosive reflux | – | Diagnostic Test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposesPatients with symptoms of reflux but no evidence of oesophagitis or Barretts oesophagus on endoscopy. |
| Patients with erosive reflux | – | Diagnostic Test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposesPatients with symptoms of reflux with evidence of oesophagitis or Barretts oesophagus on endoscopy. |
| Patients with no reflux | – | Diagnostic Test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposesPatients with healthy oesophago-gastric mucosa and no symptoms of reflux. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with erosive, non-erosive reflux and patients with no symptoms of reflux and healthy upper GI mucosa.
Key inclusion criteria (1 listed)
- Patients who deemed necessary for an upper gastro intestinal endoscopy for clinical reasons and consent for additional gastric mucosal biopsies for study purposes
Key exclusion criteria (1 listed)
- Patients who have upper GI malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposesStandard upper GI endoscopy with biopsies | Diagnostic test | Patients with erosive reflux, Patients with no reflux, Patients with non erosive reflux |
Primary outcome
Difference in the bacterial composition of the gastric mucosa between the three groups
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for GORD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GORD and Oesophageal Cancer, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the bacterial composition of the gastric mucosa between the three groups (time frame: Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.