Gastric CancerDiGMANCT03418428
Intestinal Microbiome After Gastrectomy
An observational study of Gastric Cancer, run by Vilnius University at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 34 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Apr 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome
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.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Patients who underwent total or subtotal gastrectomy for the treatment of gastric cancer | |
| Control group 1 | Patients who underwent endoscopic mucosal resection/submucosal dissection for the treatment of gastric cancer | |
| Control group 2 | In-house relatives of Test group and Control group 1 participants | |
| Control group 3 | Patients with long-term history of proton pump inhibitor usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiome composition
Significant differences in the beta-diversity of the intestinal microbiome between Test group and Control groups
Measured: 5 years after surgery
Secondary outcomes (10)
Intestinal microbiome composition (II)
Significant differences in the alpha-diversity of the intestinal microbiome between Test group and Control groups
Measured: 5 years after surgery
Fecal calprotectin
Significant differences in intestinal inflammation measured by fecal calprotectin between Test group and Control groups
Measured: 5 years after surgery
Fecal zonulin
Significant differences in intestinal permeability measured by fecal zonulin between Test group and Control groups
Measured: 5 years after surgery
Serum LPS
Significant differences in serum LPS between Test group and Control groups
Measured: 5 years after surgery
Serum sCD14
Significant differences in serum sCD14 between Test group and Control groups
Measured: 5 years after surgery
Serum LBP
Significant differences in serum LBP between Test group and Control groups
Measured: 5 years after surgery
Serum sCD163
Significant differences in serum sCD163 between Test group and Control groups
Measured: 5 years after surgery
Serum sMR
Significant differences in serum sMR between Test group and Control groups
Measured: 5 years after surgery
Serum CRP
Significant differences in serum CRP between Test group and Control groups
Measured: 5 years after surgery
Serum DAO
Significant differences in serum DAO between Test group and Control groups
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Apr 2018
- Primary completion30 Jun 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rimantas Bausys, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418428
- Sponsor's protocol ID
- DiGMA_2018
- Acronym
- DiGMA
- Status last verified
- Dec 2019
- First submitted
- 2 Jan 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The use of sequence data repositories is planed
Publications
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.
PubMed 32504369
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Gastric Cancer Treatment: Influence on Intestinal Microbiome
- ClinicalTrials.gov ID
- NCT03418428
- Acronym / sponsor ID
- DiGMA / DiGMA_2018
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Medical University of Graz, National Cancer Institute (NCI)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test group | – | –Patients who underwent total or subtotal gastrectomy for the treatment of gastric cancer |
| Control group 1 | – | –Patients who underwent endoscopic mucosal resection/submucosal dissection for the treatment of gastric cancer |
| Control group 2 | – | –In-house relatives of Test group and Control group 1 participants |
| Control group 3 | – | –Patients with long-term history of proton pump inhibitor usage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Intestinal microbiome composition (II)
Time frame: 5 years after surgery
Fecal calprotectin
Time frame: 5 years after surgery
Fecal zonulin
Time frame: 5 years after surgery
Serum LPS
Time frame: 5 years after surgery
Serum sCD14
Time frame: 5 years after surgery
Serum LBP
Time frame: 5 years after surgery
Serum sCD163
Time frame: 5 years after surgery
Serum sMR
Time frame: 5 years after surgery
Serum CRP
Time frame: 5 years after surgery
Serum DAO
Time frame: 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Derived from this study: PubMed 32504369Horvath 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.
- Individual participant dataSharing planned: Undecided. The use of sequence data repositories is planed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal microbiome composition (time frame: 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020; AzTrials last refreshed its copy on 2 Nov 2026.