NCT06019312

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

The Impact of Lactobacillus Plantarum 299v in Combination With Inulin on Gut Microbiome, Chemotherapy and Radiotherapy-induced Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients in Periooperative Period

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colorectal Cancer
• Clostridioides Difficile Infection
• Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sanprobi IBS®	Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-05-30
• Completion: 2024-06-01
• First posted: 2023-08-31
• Last updated: 2023-08-31

Locations

1 site across 1 country: Poland