Clinical trial NCT06250075: Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Adenocarcinoma
Gastric Cancer
Microbiome
Cytokines
Nutritional Status
Keywords: Gastric Cancer
Microbiome
Nutritional Status
Cytokines
Lead sponsor: Universidade Federal do Amazonas
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In time 1 of the research, patients will be distributed through the Randomizer Clinical Trial Lite application into 4 groups (G1, G2, G4 and G5) to receive 1 capsule a day of probiotics (groups G1 and G4) will receive a formulation containing 20 billion of microorganisms. In group G2 (no intervention), treatment with standard nutrition, without the use of probiotics. The intervention product (probiotic capsules) will be distributed and packaged according to randomization for blinding. In the case of group G3 (control), they will receive probiotic capsules after the end of groups G1 and G2. Both groups that will use probiotic capsules, 1 capsule per day, in the same shift, must continue for 7 days, without interruption in monitoring. In relation to groups G4 and G5, they constitute time 2 of the research, with G4 being the group that will use probiotics following the G1 standard and G5 will use placebo capsules with 0.5g of calcium carbonate to test the power of the intervention.
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Modulation of the Immune Response
timeFrame: twelve months
measure: Modulation of the Intestinal Microbiota
timeFrame: twelve months
measure: The use of probiotics can modify the incidence of postoperative complications
timeFrame: twelve months
Secondary outcomes:
measure: Modulation of nutritional parameters with the use of probiotics-weight and height
timeFrame: twelve months
measure: Modulation of nutritional parameters using probiotics-phase angle
timeFrame: twelve months
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Abner Souza Paz
state: AM
Study officials:
References: