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Intestinal Microbiome After Gastrectomy (DiGMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418428
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
Medical University of Graz
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rimantas Bausys, Vilnius University

Study Description
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Brief Summary:

The gastric barrier plays a major role in the maintanance of the distal intestinal microbiome composition. It has been shown before that the use of gastric acid suppression medication, such as proton pump inhibitors, are associated with distinctive alterations of the intestinal microbiome. Foremost, the invasion of predominantly oral bacteria, like Veillonella and Streptococcus species, were a resurring finding in previous reports.

Gastric cancer treatment includes the total or subtotal resection of the stomach which can influence the gastric acid production. However, the influence by alterations in gastric milieu after this treatment on the composition of the intestinal microbiome is not well studied.

Therefore, the intestinal microbiome of patients after total or subtotal gastrectomy and its influence on intestinal inflammation and gut permeability will be studied.


Condition or disease
Gastric Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Group/Cohort
Test group
Patients who underwent total or subtotal gastrectomy for the treatment of gastric cancer
Control group 1
Patients who underwent endoscopic mucosal resection/submucosal dissection for the treatment of gastric cancer
Control group 2
In-house relatives of Test group and Control group 1 participants
Control group 3
Patients with long-term history of proton pump inhibitor usage


Outcome Measures
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Primary Outcome Measures :
  1. Intestinal microbiome composition [ Time Frame: 5 years after surgery ]
    Significant differences in the beta-diversity of the intestinal microbiome between Test group and Control groups


Secondary Outcome Measures :
  1. Intestinal microbiome composition (II) [ Time Frame: 5 years after surgery ]
    Significant differences in the alpha-diversity of the intestinal microbiome between Test group and Control groups

  2. Fecal calprotectin [ Time Frame: 5 years after surgery ]
    Significant differences in intestinal inflammation measured by fecal calprotectin between Test group and Control groups

  3. Fecal zonulin [ Time Frame: 5 years after surgery ]
    Significant differences in intestinal permeability measured by fecal zonulin between Test group and Control groups

  4. Serum LPS [ Time Frame: 5 years after surgery ]
    Significant differences in serum LPS between Test group and Control groups

  5. Serum sCD14 [ Time Frame: 5 years after surgery ]
    Significant differences in serum sCD14 between Test group and Control groups

  6. Serum LBP [ Time Frame: 5 years after surgery ]
    Significant differences in serum LBP between Test group and Control groups

  7. Serum sCD163 [ Time Frame: 5 years after surgery ]
    Significant differences in serum sCD163 between Test group and Control groups

  8. Serum sMR [ Time Frame: 5 years after surgery ]
    Significant differences in serum sMR between Test group and Control groups

  9. Serum CRP [ Time Frame: 5 years after surgery ]
    Significant differences in serum CRP between Test group and Control groups

  10. Serum DAO [ Time Frame: 5 years after surgery ]
    Significant differences in serum DAO between Test group and Control groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Test group: Patients with a history of gastric cancer surgery, without the current use of PPI and no recurrence of gastric cancer and a minimum of 12 months since the last adjuvant treatment Control group 1: Patients with a history of endoscopic resection of gastric cancer, without the current use of PPI and no recurrence of gastric cancer Control group2: Healthy volunteers recruited from relatives of study participants (Test group and Control group 1), without the current use of PPI Control group 3: Patients with a history of long-term PPI usage (6 months) without a history of gastric cancer
Criteria

Inclusion Criteria:

  • age 18 years and above
  • history of radical removal of gastric cancer (Test group and Control group 1) or PPI (Control group 3)
  • informed consent

Exclusion Criteria:

  • chemotherapy or radiotherapy 12 months prior to inclusion
  • gastric stump cancer
  • usage of antibiotics, pro- pre or synbiotics, H2-blocker 1 month prior to inclusion
  • PPI use (except for Control group 3) 1 month prior to inclusion
  • history of radical removal of gastric cancer (Control group 2-3)
  • history of gastrointestinal tract resections (other than gastric)
  • recurrence of gastric cancer
  • current non-gastric malignancies
Contacts and Locations
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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): NCT03418428


Locations
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Lithuania
National Cancer Institute
Vilnius, Lithuania
Sponsors and Collaborators
Vilnius University
Medical University of Graz
National Cancer Institute (NCI)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rimantas Bausys, Medical Doctor, Vilnius University
ClinicalTrials.gov Identifier: NCT03418428    
Other Study ID Numbers: DiGMA_2018
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The use of sequence data repositories is planed

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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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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases