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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastric Adenocarcinoma
- Sponsor
- Universidade Federal do Amazonas
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Modulation of the Intestinal Microbiota
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Abner Souza Paz, RD
Principal Investigator
Universidade Federal do Amazonas
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Modulation of the Intestinal Microbiota
Time Frame: twelve months
The use of probiotics positively interfered in maintaining a change in the pre-surgical microbial profile, in relation to the post-surgical one.
Modulation of the Immune Response
Time Frame: twelve months
We will measure (measure the concentration) of inflammatory cytokines through flow cytometry, and then observe whether the intervention interferes negatively or positively in the inflammatory pattern.
The use of probiotics can modify the incidence of postoperative complications
Time Frame: twelve months
During surgery, many inflammatory factors can interfere with the appearance of postoperative complications. We assume that the use of probiotics can beneficially modulate surgical complications.
Secondary Outcomes
- Modulation of nutritional parameters with the use of probiotics-weight and height(twelve months)
- Modulation of nutritional parameters using probiotics-phase angle(twelve months)