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Trial record 1 of 9 for:    Bacterial Esophagitis
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The Bacterial Composition of the Stomach in Reflux Disease

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ClinicalTrials.gov Identifier: NCT03835663
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
GORD Oesophageal Cancer Oesophageal Reflux Gastric Cancer Gastro Esophageal Reflux Oesophageal Carcinoma Barrett Esophagus Esophagitis Diagnostic Test: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Bacteria Responsible for the the Development of Oesophago-gastric Cancer
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Group/Cohort Intervention/treatment
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
Standard upper GI endoscopy with biopsies

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
Standard upper GI endoscopy with biopsies

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
Standard upper GI endoscopy with biopsies




Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples With DNA
Endoscopic biopsy from gastric mucosa Saliva Liquid gastric content


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835663


Contacts
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Contact: Matyas Fehervari, PhD +447523400179 matyas.fehervari15@imperial.ac.uk

Locations
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United Kingdom
Imperial College Healthcare, St Mary's Hospital, Paddington Recruiting
London, United Kingdom, W2 1NY
Contact: Matyas Fehervari, PhD    +447523400179    matyas.fehervari15@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03835663     History of Changes
Other Study ID Numbers: R18055
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophagitis
Stomach Neoplasms
Barrett Esophagus
Esophageal Neoplasms
Gastroesophageal Reflux
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastroenteritis
Precancerous Conditions
Head and Neck Neoplasms