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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Colorectal Cancer, Clostridioides Difficile Infection, Diarrhea

Intervention / Treatment
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* Dietary Supplement: Sanprobi IBS®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus plantarum 299v<br>15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks | Dietary Supplement: Sanprobi IBS®<br>* Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.<br>|
| Experimental: Lactobacillus plantarum 299v in combination with inulin<br>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®<br>* Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.<br>|
| No Intervention: Placebo in combination with inulin<br>15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks | |
| No Intervention: Placebo<br>15 patients will receive 2 capsules (per day) of placebo for 4 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus plantarum 299v, Probiotics, Colorectal Cancer, Clostridioides difficile, Diarrhea