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

Sponsor

Medical University of Gdansk (Other)

Overall Status

Recruiting

CT.gov ID

NCT06019312

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Clostridioides Difficile Infection Diarrhea	Dietary Supplement: Sanprobi IBS®	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

May 30, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus plantarum 299v 15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks	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.
Experimental: Lactobacillus plantarum 299v in combination with inulin 15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks	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.
No Intervention: Placebo in combination with inulin 15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks
No Intervention: Placebo 15 patients will receive 2 capsules (per day) of placebo for 4 weeks

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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