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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06019312
Other study ID # MUGdansk_Lp299v
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date June 1, 2024

Study information

Verified date August 2023
Source Medical University of Gdansk
Contact Karolina Kazmierczak-Siedlecka, PhD
Phone 607507240
Email leokadia@gumed.edu.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 1, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Poland Unit of Surgery with Unit of Oncological Surgery in Koscierzyna Koscierzyna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 chemotherapy and radiotherapy-induced diarrhoea It will be analysed by using own created survey. 4 weeks
Secondary Clostridioides difficile infection The incidence of Clostridioides difficile infection will be noted. 6 months
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