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Completed

NCT Number: NCT03418428

Intestinal Microbiome After Gastrectomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute

Vilnius, Lithuania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • Medical University of Graz
  • National Cancer Institute (NCI)

Registry information

Official study title

Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome

Acronym: DiGMA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2018
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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