An observational study in Gastric Cancer, sponsored by Vilnius University. Completed at 1 site in Lithuania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by Vilnius University · Observational
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.
Test group: Patients with a history of gastric cancer surgery, without the current use of PPI and no recurrence of gastric cancer and a minimum of 12 months since the last adjuvant treatment Control group 1: Patients with a history of endoscopic resection of gastric cancer, without the current use of PPI and no recurrence of gastric cancer Control group2: Healthy volunteers recruited from relatives of study participants (Test group and Control group 1), without the current use of PPI Control group 3: Patients with a history of long-term PPI usage (6 months) without a history of gastric cancer
Exclusion Criteria:
Patients who underwent total or subtotal gastrectomy for the treatment of gastric cancer
Patients who underwent endoscopic mucosal resection/submucosal dissection for the treatment of gastric cancer
In-house relatives of Test group and Control group 1 participants
Patients with long-term history of proton pump inhibitor usage
Intestinal microbiome composition
Significant differences in the beta-diversity of the intestinal microbiome between Test group and Control groups
Time frame: 5 years after surgery
Intestinal microbiome composition (II)
Significant differences in the alpha-diversity of the intestinal microbiome between Test group and Control groups
Time frame: 5 years after surgery
Fecal calprotectin
Significant differences in intestinal inflammation measured by fecal calprotectin between Test group and Control groups
Time frame: 5 years after surgery
Fecal zonulin
Significant differences in intestinal permeability measured by fecal zonulin between Test group and Control groups
Time frame: 5 years after surgery
Serum LPS
Significant differences in serum LPS between Test group and Control groups
Time frame: 5 years after surgery
Serum sCD14
Significant differences in serum sCD14 between Test group and Control groups
Time frame: 5 years after surgery
Serum LBP
Significant differences in serum LBP between Test group and Control groups
Time frame: 5 years after surgery
Serum sCD163
Significant differences in serum sCD163 between Test group and Control groups
Time frame: 5 years after surgery
Serum sMR
Significant differences in serum sMR between Test group and Control groups
Time frame: 5 years after surgery
Serum CRP
Significant differences in serum CRP between Test group and Control groups
Time frame: 5 years after surgery
Serum DAO
Significant differences in serum DAO between Test group and Control groups
Time frame: 5 years after surgery
Plan to share: Undecided — The use of sequence data repositories is planed
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Vilnius University