Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer (PRONIC-G)

Universidade Federal do Amazonas

Status: Completed

Conditions: Nutritional Status; Gastric Cancer; Cytokines; Microbiome; Gastric Adenocarcinoma

Treatments: Dietary Supplement: Formulation with probiotics; Other: Non-intervention for Clinical Outcomes -G5

Study type: Interventional

Funder types: Other

Identifiers

NCT06250075

6.014.436

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 5 patient groups, including a placebo group

G1 Intervention Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Formulation with probiotics

Non-Intervention Group G2

No Intervention group

Description:

Group G2 followed general nutritional guidelines. This group will not take probiotics, it will be the surgical comparator.

G3 Negative Control Group

Sham Comparator group

Description:

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

Treatment:

Dietary Supplement: Formulation with probiotics

Intervention for Clinical Outcomes -G4

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Formulation with probiotics

Non-intervention for Clinical Outcomes -G5

Placebo Comparator group

Description:

G5 will use placebo capsules with 0.5g calcium carbonate to test the power of the intervention in reducing postoperative surgical complications or not.

Treatment:

Other: Non-intervention for Clinical Outcomes -G5