Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer (NCT06250075) | Clinical Trial Compass
CompletedNot Applicable
Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer
Brazil88 participantsStarted 2020-12-12
Plain-language summary
The objective of this randomized controlled, prospective clinical study, composed of 5 groups, G1, G2, G3, G4 and G5 is \[Evaluate the intestinal microbiota profile, nutritional, immunological status and inflammatory profile, before and after total or partial removal surgery (gastrectomies) for gastric cancer, in a patient using probiotic supplements.\] The main questions it aims to answer are:
* probiotics are capable of modulating the immune response and microbiota in cancer patients who will undergo surgery
* surgery itself alters the immunological pattern and microbiota of cancer patients Participants will be divided into groups for evaluation and the G1 intervention group will take probiotic capsules.
The researchers will compare groups G1, G2 with G3 (negative control group) to see if there are differences between using probiotics or not, in controlling the immune response and if there are significant changes in their intestinal microbiota. Groups G4 and G5 will also be compared, where in these we will only measure the power of the use of probiotics in reducing surgical complications in the postoperative period.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with indication for total or partial gastrectomy;
* Ages from 18 years old.
Exclusion Criteria:
* Palliative patients
* Use of probiotics and prebiotics in the last 15 days;
* Patients who are unable to complete all monitoring steps;
* AIDS patients;
* Diabetic patients;
* Pregnant patients;
* Patients with Autoimmune Diseases;
* Patients with Liver Diseases;
* Patients with Kidney Disease;
* Patients with Inflammatory Bowel Diseases.
* Patients who have MCP (pacemaker),
* Patients with severe Edema,
* Patients with titanium plates in any limb of the body
* Patients who for some reason had their surgeries suspended during follow-up.
* Patients undergoing mechanical colon preparation in the last 30 days.
* Patients not resident/domiciled in Amazonas.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modulation of the Immune Response
Timeframe: twelve months
2
Modulation of the Intestinal Microbiota
Timeframe: twelve months
3
The use of probiotics can modify the incidence of postoperative complications