Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer

Not Applicable

Completed

• Conditions: Cytokines; Gastric Adenocarcinoma; Microbiome; Nutritional Status; Gastric Cancer
• Interventions: Other: Non-intervention for Clinical Outcomes -G5; Dietary Supplement: Formulation with probiotics

• Registration Number: NCT06250075
• Lead Sponsor: Universidade Federal do Amazonas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-12
• Primary Completion: 2022-08-04
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Study Completion: 2024-04-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-intervention for Clinical Outcomes -G5	Non-intervention for Clinical Outcomes -G5	G5 will use placebo capsules with 0.5g calcium carbonate to test the power of the intervention in reducing postoperative surgical complications or not.
G1 Intervention Group	Formulation with probiotics	In group 1, the intervention will take place with intake from the 1st day Post-OP when releasing the diet (Orally or ENT) and up to 7 days post-operatively with probiotic capsules.
Intervention for Clinical Outcomes -G4	Formulation with probiotics	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.
G3 Negative Control Group	Formulation with probiotics	Group G3 (guest employees) will follow the intake of probiotic capsules for 7 days during follow-up, without surgical intervention, these will be chosen at random and standardized by social level paired with G1

Primary Outcome Measures

Name	Time	Method
Modulation of the Intestinal Microbiota	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	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	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 Outcome Measures

Name	Time	Method
Modulation of nutritional parameters with the use of probiotics-weight and height	twelve months	Nutritional measurements such as weight and height will be combined to obtain BMI and evaluate body mass, as biological markers that can be modulated with the use of probiotics.
Modulation of nutritional parameters using probiotics-phase angle	twelve months	Nutritional measurements such as phase angle (a measurement obtained by applying electrical bioimpendance, as a biological marker that can be modulated with the use of probiotics

Trial Locations

Locations (1)

Abner Souza Paz; 🇧🇷 Manaus, AM, Brazil