Effects of L. Plantarum 299v on gut health 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
This study is testing if a probiotic called L. plantarum 299v can improve gut health and reduce diarrhea in colorectal cancer patients who are having surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of Gdansk Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kościerzyna) |
| Trial ID | NCT06019312 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of the probiotic L. plantarum 299v on gut microbiome health, diarrhea, and Clostridioides difficile infection in colorectal cancer patients undergoing surgery. A total of 60 participants will be divided into four groups, with some receiving the probiotic, others receiving a combination of the probiotic and inulin, while control groups will receive placebos. The study aims to assess the efficacy of these interventions over a four-week period. Participants will be monitored for gastrointestinal health and infection rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with colorectal cancer who are preparing for surgical treatment.
Not a fit: Patients with other cancers, inflammatory bowel diseases, or those who have recently taken certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve gut health and reduce the incidence of diarrhea and infections in colorectal cancer patients.
How similar studies have performed: Previous studies have shown promising results with probiotics in managing gut health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kościerzyna
- Unit of Surgery with Unit of Oncological Surgery in Koscierzyna — Kościerzyna, Poland (Recruiting)
Study contacts
- Study coordinator: Karolina Kaźmierczak-Siedlecka, PhD
- Email: leokadia@gumed.edu.pl
- Phone: 607507240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.