<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03835663</url>
  </required_header>
  <id_info>
    <org_study_id>R18055</org_study_id>
    <nct_id>NCT03835663</nct_id>
  </id_info>
  <brief_title>The Bacterial Composition of the Stomach in Reflux Disease</brief_title>
  <official_title>Identification of Bacteria Responsible for the the Development of Oesophago-gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastric and oesophageal (OG) cancer associated with poor long term outcome as overall less&#xD;
      than 25% of patients survive for more than 5 years due to late recognition of the disease.&#xD;
      Growing evidence suggests an important role for bacteria in OG cancer and gastro esophageal&#xD;
      reflux disease (GORD) development. About 1 in 10 people suffer from GORD and this one of the&#xD;
      most common conditions leading to gastric and oesophageal cancer.&#xD;
&#xD;
      In GORD surgical therapy is the most successful preventing cancer but around 85% of patient&#xD;
      experience complications afterwards. Acid suppressing medications are reducing the risk of&#xD;
      oesophageal cancer but equally increasing the risk of gastric cancer. They also shorten&#xD;
      patients' life expectancy and often fail to provide relief. Analysis of stool samples of&#xD;
      patients with GORD demonstrated different gut bacterial compositions to normal and rather&#xD;
      resembled the one found in cancer.&#xD;
&#xD;
      There is a clear need to improve the outcome of OG cancer. This could be achieved by&#xD;
      identifying bacteria responsible for cancer development in gastric tissue, gastric content&#xD;
      and saliva and potentially eliminate them hence avoid the development of cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 4, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 7, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the bacterial composition of the gastric mucosa between the three groups</measure>
    <time_frame>Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C</time_frame>
    <description>Bacterias found in the stomach will be identified with 16s RNA analysis. The type of bacterias identified will be compared between the three groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in the amount of bacteria of the gastric mucosa between the three previously described groups.</measure>
    <time_frame>Samples are collected on the day of endoscopy following min 6 hours starvation and preserved on -80C</time_frame>
    <description>Bacterias found in the gastric mucosa will be quantified and compared within the three groups.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>GORD</condition>
  <condition>Oesophageal Cancer</condition>
  <condition>Oesophageal Reflux</condition>
  <condition>Gastric Cancer</condition>
  <condition>Gastro Esophageal Reflux</condition>
  <condition>Oesophageal Carcinoma</condition>
  <condition>Barrett Esophagus</condition>
  <condition>Esophagitis</condition>
  <arm_group>
    <arm_group_label>Patients with non erosive reflux</arm_group_label>
    <description>Patients with symptoms of reflux but no evidence of oesophagitis or Barretts oesophagus on endoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with erosive reflux</arm_group_label>
    <description>Patients with symptoms of reflux with evidence of oesophagitis or Barretts oesophagus on endoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with no reflux</arm_group_label>
    <description>Patients with healthy oesophago-gastric mucosa and no symptoms of reflux.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes</intervention_name>
    <description>Standard upper GI endoscopy with biopsies</description>
    <arm_group_label>Patients with erosive reflux</arm_group_label>
    <arm_group_label>Patients with no reflux</arm_group_label>
    <arm_group_label>Patients with non erosive reflux</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Endoscopic biopsy from gastric mucosa Saliva Liquid gastric content&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with erosive, non-erosive reflux and patients with no symptoms of reflux and&#xD;
        healthy upper GI mucosa.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who deemed necessary for an upper gastro intestinal endoscopy for clinical&#xD;
             reasons and consent for additional gastric mucosal biopsies for study purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have upper GI malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matyas Fehervari, PhD</last_name>
    <phone>+447523400179</phone>
    <email>matyas.fehervari15@imperial.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Imperial College Healthcare, St Mary's Hospital, Paddington</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matyas Fehervari, PhD</last_name>
      <phone>+447523400179</phone>
      <email>matyas.fehervari15@imperial.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Barrett Esophagus</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03835663
org study id: R18055
nct id: NCT03835663
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
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
description: Bacterias found in the stomach will be identified with 16s RNA analysis. The type of bacterias identified will be compared between the three groups.
measure: 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
description: Bacterias found in the gastric mucosa will be quantified and compared within the three groups.
arm group label: Patients with non erosive reflux
description: Patients with symptoms of reflux but no evidence of oesophagitis or Barretts oesophagus on endoscopy.
arm group label: Patients with erosive reflux
description: Patients with symptoms of reflux with evidence of oesophagitis or Barretts oesophagus on endoscopy.
arm group label: Patients with no reflux
description: Patients with healthy oesophago-gastric mucosa and no symptoms of reflux.
intervention type: Diagnostic Test
intervention name: No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes
description: Standard upper GI endoscopy with biopsies
arm group label: Patients with erosive reflux
arm group label: Patients with no reflux
arm group label: Patients with non erosive reflux
Endoscopic biopsy from gastric mucosa Saliva Liquid gastric content
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matyas Fehervari, PhD
phone: +447523400179
email: matyas.fehervari15@imperial.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Barrett Esophagus
mesh term: Esophageal Neoplasms
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis
sharing ipd: No