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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06019312

Enrollment

Registered

2023-08-31

Start date

2023-08-01

Completion date

2024-06-01

Last updated

2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridioides Difficile Infection, Colorectal Cancer, Diarrhea

Keywords

Lactobacillus plantarum 299v, Probiotics, Colorectal Cancer, Clostridioides difficile, Diarrhea

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

Interventions

DIETARY_SUPPLEMENTSanprobi IBS®

Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
gut microbiota composition	4 weeks	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

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

Countries

Poland

Contacts

Primary ContactKarolina Kaźmierczak-Siedlecka, PhD

leokadia@gumed.edu.pl607507240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026