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Intestinal Microbiome After Gastrectomy (DiGMA)

V

Vilnius University

Status

Completed

Conditions

Gastric Cancer

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT03418428
DiGMA_2018

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

34 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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