NCT06250075Completed
Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer
Effects of the Use of Probiotics on the Intestinal Microbiota, Clinical-Nutritional and Immunological Status of Patients Gastrectomized for Gastric Cancer: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 5 Jan 2024
- Start date
- 12 Dec 2020
- Primary completion date
- 4 Aug 2022
- Lead sponsor
- Universidade Federal do Amazonas
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06250075
What you commit to
- Study type: Interventional
- Participants enrolled: 88
- From 12 Dec 2020 to the primary completion date, 4 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with Autoimmune Diseases;
- Patients with Liver Diseases;
- Patients with Kidney Disease;
- Patients with Inflammatory Bowel Diseases.
Other
- 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 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.
Who the study is looking for
- Patients with indication for total or partial gastrectomy;
- Ages from 18 years old.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abner Souza Paz Coordinator of this site? Confirm its status | Manaus | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.