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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Modulation of the Intestinal Microbiota
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
For the first stage of the research, patients eligible for cancer gastrectomies were invited at FCECON on an outpatient basis or through the surgical map on the day of admission. Randomization took place through a specific application called Randomizer for Clinical Trial Lite. Different wards were assigned to each group to avoid contact between research participants (G1 intervention and G2 non-intervention). For the G3 (control) group, they will be recruited by invitation, they must be FCECON employees, this group will specifically be matched by the socioeconomic level of the patients in the G1 group. The G4 and G5 groups will be recruited and randomized in the second stage of the research after the end of the collection of the G1 and G2 groups, for analysis of clinical outcomes in the 7-day postoperative period.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indication for total or partial gastrectomy;
- •Ages from 18 years old.
排除标准
- •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.
结局指标
主要结局
Modulation of the Intestinal Microbiota
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Modulation of nutritional parameters with the use of probiotics-weight and height(twelve months)
- Modulation of nutritional parameters using probiotics-phase angle(twelve months)
研究者
Abner Souza Paz, RD
Principal Investigator
Universidade Federal do Amazonas