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

Gastric Cancer Clinical Trial

— PRONIC-G  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06250075
• Other study ID #: 6.014.436
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: April 26, 2024

Study information

• Verified date: May 2024
• Source: Universidade Federal do Amazonas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 26, 2024
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cytokines
• Gastric Adenocarcinoma
• Gastric Cancer
• Microbiome
• Nutritional Status
• Stomach Neoplasms

Intervention

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:
• Non-intervention for Clinical Outcomes -G5
only observation of clinical outcomes in the postoperative period

Locations

Country	Name	City	State
Brazil	Abner Souza Paz	Manaus	AM

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Amazonas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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