Intestinal Microbiome After Gastrectomy

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT03418428
• Lead Sponsor: Vilnius University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-01
• Study Start: 2018-04-01
• Primary Completion: 2019-06-30
• Status Verified: 2019-12
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-29
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal microbiome composition	5 years after surgery	Significant differences in the beta-diversity of the intestinal microbiome between Test group and Control groups

Secondary Outcome Measures

Name	Time	Method
Intestinal microbiome composition (II)	5 years after surgery	Significant differences in the alpha-diversity of the intestinal microbiome between Test group and Control groups
Fecal calprotectin	5 years after surgery	Significant differences in intestinal inflammation measured by fecal calprotectin between Test group and Control groups
Fecal zonulin	5 years after surgery	Significant differences in intestinal permeability measured by fecal zonulin between Test group and Control groups
Serum LBP	5 years after surgery	Significant differences in serum LBP between Test group and Control groups
Serum LPS	5 years after surgery	Significant differences in serum LPS between Test group and Control groups
Serum sCD14	5 years after surgery	Significant differences in serum sCD14 between Test group and Control groups
Serum sMR	5 years after surgery	Significant differences in serum sMR between Test group and Control groups
Serum sCD163	5 years after surgery	Significant differences in serum sCD163 between Test group and Control groups
Serum CRP	5 years after surgery	Significant differences in serum CRP between Test group and Control groups
Serum DAO	5 years after surgery	Significant differences in serum DAO between Test group and Control groups

Trial Locations

Locations (1)

National Cancer Institute; 🇱🇹 Vilnius, Lithuania