Intestinal Microbiome After Gastrectomy

Gastric Cancer Clinical Trial

— DiGMA  

Official title:

Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418428
• Other study ID #: DiGMA_2018
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 1, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Lithuania	National Cancer Institute	Vilnius

Sponsors (3)

Lead Sponsor	Collaborator
Vilnius University	Medical University of Graz, National Cancer Institute (NCI)

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal microbiome composition	Significant differences in the beta-diversity of the intestinal microbiome between Test group and Control groups	5 years after surgery
Secondary	Intestinal microbiome composition (II)	Significant differences in the alpha-diversity of the intestinal microbiome between Test group and Control groups	5 years after surgery
Secondary	Fecal calprotectin	Significant differences in intestinal inflammation measured by fecal calprotectin between Test group and Control groups	5 years after surgery
Secondary	Fecal zonulin	Significant differences in intestinal permeability measured by fecal zonulin between Test group and Control groups	5 years after surgery
Secondary	Serum LPS	Significant differences in serum LPS between Test group and Control groups	5 years after surgery
Secondary	Serum sCD14	Significant differences in serum sCD14 between Test group and Control groups	5 years after surgery
Secondary	Serum LBP	Significant differences in serum LBP between Test group and Control groups	5 years after surgery
Secondary	Serum sCD163	Significant differences in serum sCD163 between Test group and Control groups	5 years after surgery
Secondary	Serum sMR	Significant differences in serum sMR between Test group and Control groups	5 years after surgery
Secondary	Serum CRP	Significant differences in serum CRP between Test group and Control groups	5 years after surgery
Secondary	Serum DAO	Significant differences in serum DAO between Test group and Control groups	5 years after surgery