Back to resultsL. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients
Primary Purpose
Colorectal Cancer, Clostridioides Difficile Infection, Diarrhea
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Sanprobi IBS®
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Lactobacillus plantarum 299v, Probiotics, Colorectal Cancer, Clostridioides difficile, Diarrhea
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
Sites / Locations
- Unit of Surgery with Unit of Oncological Surgery in KoscierzynaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
No Intervention
Arm Label
Lactobacillus plantarum 299v
Lactobacillus plantarum 299v in combination with inulin
Placebo in combination with inulin
Placebo
Arm Description
15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks
15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks
15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks
15 patients will receive 2 capsules (per day) of placebo for 4 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
chemotherapy and radiotherapy-induced diarrhoea
It will be analysed by using own created survey.
Clostridioides difficile infection
The incidence of Clostridioides difficile infection will be noted.
Full Information
NCT ID
NCT06019312
First Posted
August 10, 2023
Last Updated
August 24, 2023
Sponsor
Medical University of Gdansk
1. Study Identification
Unique Protocol Identification Number
NCT06019312
Brief Title
L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Gdansk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Clostridioides Difficile Infection, Diarrhea
Keywords
Lactobacillus plantarum 299v, Probiotics, Colorectal Cancer, Clostridioides difficile, Diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus plantarum 299v
Arm Type
Experimental
Arm Description
15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks
Arm Title
Lactobacillus plantarum 299v in combination with inulin
Arm Type
Experimental
Arm 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
Arm Title
Placebo in combination with inulin
Arm Type
No Intervention
Arm Description
15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
15 patients will receive 2 capsules (per day) of placebo for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Sanprobi IBS®
Intervention Description
Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.
Primary Outcome Measure Information:
Title
gut microbiota composition
Description
It will be measured by presenting alpha diversity and beta-diversity of microbial community and after that it will be presented using bioinformatic analysis.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
chemotherapy and radiotherapy-induced diarrhoea
Description
It will be analysed by using own created survey.
Time Frame
4 weeks
Title
Clostridioides difficile infection
Description
The incidence of Clostridioides difficile infection will be noted.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karolina Kaźmierczak-Siedlecka, PhD
Phone
607507240
Email
leokadia@gumed.edu.pl
Facility Information:
Facility Name
Unit of Surgery with Unit of Oncological Surgery in Koscierzyna
City
Kościerzyna
ZIP/Postal Code
83-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paweł Ulasiński
Phone
537168985
Email
ulasinskipawel@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients
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