L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients

N/AUnknownNCT06019312

Medical University of Gdansk60 enrolled

Overview

Colorectal cancer in periooperative period patients (n=60) will be enrolled to this study. Participants will be divided into 4 groups as follows: * group 1 (n=15) will receive 2 capsules (per day) of L. plantarum 299v L. plantarum 299v (Sanprobi IBS®) for 4 weeks * group 2 (n=15) will receive L. plantarum 299v (2 capsules per day) and inulin (4 g) for 4 weeks * group 3 (n=15) will receive placebo (2 capsules per day) and inulin (4 g) for 4 weeks * group 4 (n=15) will receive placebo (2 capsules per day) for 4 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Colorectal Cancer Clostridioides Difficile Infection Diarrhea

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age ≥18 oraz ≤65 * patients with colorectal cancer prior to surgical treatment * qualification to surgery * the treatment with chemotherapy and radiotherapy in preoperative period * an appropriate swallowing * patients agreement to take part in this study Exclusion Criteria: * the presence of other cancers than colorectal cancer * inflammatory bowel diseases * dysphagia * intake of antibiotics, proton pump inhibitors, probiotics, and synbiotics 3 months befor taking part in this study

Outcomes

Primary Outcomes

gut microbiota composition

It will be measured by presenting alpha diversity and beta-diversity of microbial community and after that it will be presented using bioinformatic analysis.

Time frame: 4 weeks

Secondary Outcomes

chemotherapy and radiotherapy-induced diarrhoea

It will be analysed by using own created survey.

Time frame: 4 weeks

Clostridioides difficile infection

The incidence of Clostridioides difficile infection will be noted.

Time frame: 6 months