Intestinal Microbiome After Gastrectomy

NCT ID: NCT03418428

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Test group

Patients who underwent total or subtotal gastrectomy for the treatment of gastric cancer

No interventions assigned to this group

Control group 1

Patients who underwent endoscopic mucosal resection/submucosal dissection for the treatment of gastric cancer

No interventions assigned to this group

Control group 2

In-house relatives of Test group and Control group 1 participants

No interventions assigned to this group

Control group 3

Patients with long-term history of proton pump inhibitor usage

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Graz

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Rimantas Bausys

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cancer Institute

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

References

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Horvath A, Bausys A, Sabaliauskaite R, Stratilatovas E, Jarmalaite S, Schuetz B, Stiegler P, Bausys R, Stadlbauer V, Strupas K. Distal Gastrectomy with Billroth II Reconstruction is Associated with Oralization of Gut Microbiome and Intestinal Inflammation: A Proof-of-Concept Study. Ann Surg Oncol. 2021 Feb;28(2):1198-1208. doi: 10.1245/s10434-020-08678-1. Epub 2020 Jun 5.

Reference Type DERIVED
PMID: 32504369 (View on PubMed)

Other Identifiers

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DiGMA_2018

Identifier Type: -

Identifier Source: org_study_id

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