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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Nutritional Status; Gastric Adenocarcinoma; Cytokines; Microbiome
• Intervention / Treatment: Dietary supplement: Formulation with probiotics; Other: Non-intervention for Clinical Outcomes -G5

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • AM
    • Manaus, AM, Brazil, 69043160
      • Abner Souza Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G1 Intervention Group; 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.	Dietary supplement: Formulation with probiotics; Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37 ™, Bifidobacterium lactis Bi-04™, Bifidobacterium lactis Bi-07™, Bifidobacterium bifidum Bb-02™); Other Names: G1 Intervention Group; G3 Negative Control Group; Intervention for Clinical Outcomes -G4
No Intervention: Non-Intervention Group G2; Group G2 followed general nutritional guidelines. This group will not take probiotics, it will be the surgical comparator.
Sham Comparator: G3 Negative Control Group; 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	Dietary supplement: Formulation with probiotics; Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37 ™, Bifidobacterium lactis Bi-04™, Bifidobacterium lactis Bi-07™, Bifidobacterium bifidum Bb-02™); Other Names: G1 Intervention Group; G3 Negative Control Group; Intervention for Clinical Outcomes -G4
Active Comparator: Intervention for Clinical Outcomes -G4; 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.	Dietary supplement: Formulation with probiotics; Lactobacillus acidophilus NCFM®, Lactobacillus paracasei Lpc-37 ™, Bifidobacterium lactis Bi-04™, Bifidobacterium lactis Bi-07™, Bifidobacterium bifidum Bb-02™); Other Names: G1 Intervention Group; G3 Negative Control Group; Intervention for Clinical Outcomes -G4
Placebo Comparator: 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.	Other: Non-intervention for Clinical Outcomes -G5; only observation of clinical outcomes in the postoperative period; Other Names: Non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modulation of the Immune Response	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.	twelve months
Modulation of the Intestinal Microbiota	The use of probiotics positively interfered in maintaining a change in the pre-surgical microbial profile, in relation to the post-surgical one.	twelve months
The use of probiotics can modify the incidence of postoperative complications	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.	twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modulation of nutritional parameters with the use of probiotics-weight and height	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.	twelve months
Modulation of nutritional parameters using probiotics-phase angle	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	twelve months

Collaborators and Investigators

• Sponsor: Universidade Federal do Amazonas

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): April 26, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Microbiome; Gastric Cancer; Cytokines; Nutritional Status
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 6.014.436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No