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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Diarrhea; Clostridioides Difficile Infection
• Interventions: Dietary Supplement: Sanprobi IBS®

• Registration Number: NCT06019312
• Lead Sponsor: Medical University of Gdansk

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-01
• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-08-31
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus plantarum 299v	Sanprobi IBS®	15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks
Lactobacillus plantarum 299v in combination with inulin	Sanprobi IBS®	15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks

Primary Outcome Measures

Name	Time	Method
gut microbiota composition	4 weeks	It will be measured by presenting alpha diversity and beta-diversity of microbial community and after that it will be presented using bioinformatic analysis.

Secondary Outcome Measures

Name	Time	Method
chemotherapy and radiotherapy-induced diarrhoea	4 weeks	It will be analysed by using own created survey.
Clostridioides difficile infection	6 months	The incidence of Clostridioides difficile infection will be noted.

Trial Locations

Locations (1)

Unit of Surgery with Unit of Oncological Surgery in Koscierzyna; 🇵🇱 Kościerzyna, Poland