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Intestinal Microbiome After Gastrectomy

Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03418428
Acronym
DiGMA
Enrollment
34
Registered
2018-02-01
Start date
2018-04-01
Completion date
2019-12-01
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

None listed

Sponsors

Medical University of Graz
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Vilnius University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Intestinal microbiome composition5 years after surgerySignificant differences in the beta-diversity of the intestinal microbiome between Test group and Control groups

Secondary

MeasureTime frameDescription
Fecal calprotectin5 years after surgerySignificant differences in intestinal inflammation measured by fecal calprotectin between Test group and Control groups
Fecal zonulin5 years after surgerySignificant differences in intestinal permeability measured by fecal zonulin between Test group and Control groups
Serum LPS5 years after surgerySignificant differences in serum LPS between Test group and Control groups
Serum sCD145 years after surgerySignificant differences in serum sCD14 between Test group and Control groups
Intestinal microbiome composition (II)5 years after surgerySignificant differences in the alpha-diversity of the intestinal microbiome between Test group and Control groups
Serum sCD1635 years after surgerySignificant differences in serum sCD163 between Test group and Control groups
Serum sMR5 years after surgerySignificant differences in serum sMR between Test group and Control groups
Serum CRP5 years after surgerySignificant differences in serum CRP between Test group and Control groups
Serum DAO5 years after surgerySignificant differences in serum DAO between Test group and Control groups
Serum LBP5 years after surgerySignificant differences in serum LBP between Test group and Control groups

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026