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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019312
• Other study ID #: MUGdansk_Lp299v
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Medical University of Gdansk
• Contact: Karolina Kazmierczak-Siedlecka, PhD
• Phone: 607507240
• Email: leokadia[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridioides Difficile Infection
• Clostridium Infections
• Colorectal Cancer
• Colorectal Neoplasms
• Communicable Diseases
• Diarrhea
• Infections

Intervention

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.

Locations

Country	Name	City	State
Poland	Unit of Surgery with Unit of Oncological Surgery in Koscierzyna	Koscierzyna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	chemotherapy and radiotherapy-induced diarrhoea	It will be analysed by using own created survey.	4 weeks
Secondary	Clostridioides difficile infection	The incidence of Clostridioides difficile infection will be noted.	6 months