NCT06250075

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Universidade Federal do Amazonas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-12
• Primary completion: 2022-08-04
• Completion: 2024-04-26
• First posted: 2024-02-08
• Last updated: 2024-05-13

Locations

1 site across 1 country: Brazil