Evaluation of the use of Probiotics in the intestinal flora, nutritional status and immune system of patients who underwent Surgery to Remove the Stomach for Gastric Cancer
- Conditions
- Gastric NeoplasmsGastrectomyG06.591.375
- Registration Number
- RBR-5vyr8bp
- Lead Sponsor
- FAM- Universidade Federal do Amazonas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion criteria for groups G1 and G2: patients with indication for total or partial gastrectomy, with TNM staging = T1, T2, T3 (without neoadjuvant chemotherapy); patients with indication for gastrectomy only for cancer; ages between 18 to 60 years. Inclusion criteria for group G3 (negative-healthy control): People who do not have a family history of gastric cancer; people who are not blood type A+; people with no known co-morbidities; ages between 18 to 60 years; people of the same socioeconomic level (average level) of patients in the G1 group
Exclusion criteria for groups G1 and G2: Patients previously treated for other neoplasms; patients undergoing gastrectomy in the palliative setting (bleeding or obstruction); use of probiotics and prebiotics in the last 15 days; Patients who are unable to comply with all follow-up steps; patients diagnosed with other morbidities that alter energy metabolism and food intake, such as HIV/AIDS, Diabetes Mellitus; pregnant women; Autoimmune diseases; Liver and Kidney diseases; Lactose Intolerant; Gluten; Inflammatory Bowel Diseases; Infection in force; use of antibiotics 15 days before surgery; patients who are unable to perform electrical bioimpedance because they have MCP (pacemaker); edema, pregnant women; women in the menstrual period, Titanium plaques in some part of the body; indigenous; patients who for some reason had their surgeries suspended during follow-up; patients who, due to worsening of the surgical condition, need ICU; patients who underwent mechanical colonic preparation in the last 30 days; immunosuppressed patients; Patients who are not Amazonians. Exclusion criteria for group G3 (negative-healthy control): People who are unable to comply with all the stages of follow-up; use of probiotics and prebiotics in the last 15 days; use of antibiotics 15 days before the start of the research; people who are unable to perform electrical bioimpedance because they have MCP (pacemaker); edema; pregnant women; women in the menstrual period, Titanium plaques in some part of the body; indigenous
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the use of perioperative probiotics to improve the nutritional and immunological clinical status of patients undergoing gastrectomy for gastric cancer
- Secondary Outcome Measures
Name Time Method It is expected to find the profile of bacterial strains typical of the population in question, relating them to cases of gastric cancer in Amazonas, and associating the surgical type, as well as postoperative complications, using the Next Generation Sequencing method. 16S gene, and statistical methods to adjust sex, age by group whether intervention or controls