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Trial Title:
L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients
NCT ID:
NCT06019312
Condition:
Colorectal Cancer
Clostridioides Difficile Infection
Diarrhea
Conditions: Official terms:
Infections
Communicable Diseases
Clostridium Infections
Colorectal Neoplasms
Diarrhea
Conditions: Keywords:
Lactobacillus plantarum 299v
Probiotics
Colorectal Cancer
Clostridioides difficile
Diarrhea
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Sanprobi IBS®
Description:
Patients will be treated with probiotics in combination with inulin, which is able to
stimulate the growing of probiotic bacteria in gastrointestinal tract.
Arm group label:
Lactobacillus plantarum 299v
Arm group label:
Lactobacillus plantarum 299v in combination with inulin
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Unit of Surgery with Unit of Oncological Surgery in Koscierzyna
Address:
City:
Kościerzyna
Zip:
83-400
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Paweł Ulasiński
Phone:
537168985
Email:
ulasinskipawel@gmail.com
Start date:
August 1, 2023
Completion date:
June 1, 2024
Lead sponsor:
Agency:
Medical University of Gdansk
Agency class:
Other
Source:
Medical University of Gdansk
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06019312
