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

Medical University of Gdansk

Status: Enrolling

Conditions: Diarrhea; Clostridioides Difficile Infection; Colorectal Cancer

Treatments: Dietary Supplement: Sanprobi IBS®

Study type: Interventional

Funder types: Other

Identifiers

NCT06019312

MUGdansk_Lp299v

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

Lactobacillus plantarum 299v

Experimental group

Description:

15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks

Treatment:

Dietary Supplement: Sanprobi IBS®

Lactobacillus plantarum 299v in combination with inulin

Experimental group

Description:

15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks

Treatment:

Dietary Supplement: Sanprobi IBS®

Placebo in combination with inulin

No Intervention group

Description:

15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks

Placebo

No Intervention group

Description:

15 patients will receive 2 capsules (per day) of placebo for 4 weeks