Gastric Neoplasms
Conditions
Interventions
This is a three-arm, single-blind, randomized controlled clinical trial. Patients (n = 36) will be randomly distributed into three blocks (G1,G2,G3). Patients will be randomly assigned to three blocks
G07.203.300.456.500
Sponsors
UFAM- Universidade Federal do Amazonas
FCECON - Fundação Centro de Controle de Oncologia do Estado do Amazonas.
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the use of perioperative probiotics to improve the nutritional and immunological clinical status of patients undergoing gastrectomy for gastric cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Brazil
Contacts
Public ContactÁbner Paz
FCECON - Fundação Centro de Controle de Oncologia do Estado do Amazonas.
Outcome results
None listed