Clinical trial NCT03418428: Intestinal Microbiome After Gastrectomy
Official title: Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
name: National Cancer Institute (NCI)
First posted: 2018-02-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intestinal microbiome composition
timeFrame: 5 years after surgery
Secondary outcomes:
measure: Intestinal microbiome composition (II)
timeFrame: 5 years after surgery
measure: Fecal calprotectin
timeFrame: 5 years after surgery
measure: Fecal zonulin
timeFrame: 5 years after surgery
measure: Serum LPS
timeFrame: 5 years after surgery
measure: Serum sCD14
timeFrame: 5 years after surgery
measure: Serum LBP
timeFrame: 5 years after surgery
measure: Serum sCD163
timeFrame: 5 years after surgery
measure: Serum sMR
timeFrame: 5 years after surgery
measure: Serum CRP
timeFrame: 5 years after surgery
measure: Serum DAO
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
Study officials:
References:
citation: Horvath A, Bausys A, Sabaliauskaite R, Stratilatovas E, Jarmalaite S, Schuetz B, Stiegler P, Bausys R, Stadlbauer V, Strupas K. Distal Gastrectomy with Billroth II Reconstruction is Associated with Oralization of Gut Microbiome and Intestinal Inflammation: A Proof-of-Concept Study. Ann Surg Oncol. 2021 Feb;28(2):1198-1208. doi: 10.1245/s10434-020-08678-1. Epub 2020 Jun 5.