Last reviewed · How we verify
Prevention of Irinotecan Induced Diarrhea by Probiotics: A Phase III Study
Diarrhea is a relatively common complication in patients with cancer. At its inception, several mechanisms participated; malabsorption on the basis of mucositis induced by chemotherapy, dysbiosis induced by broad-spectrum antibiotics and predisposition to infectious diarrhea in immunocompromised patients. Some cytostatics and their metabolites can also induce diarrhea directly due to effect on the intestinal mucosa. Use of probiotics in prevention and treatment of diarrhea relies on both the theoretical assumptions and the results of several clinical trials. Lactic acid bacteria involved in the treatment of dysbiosis, compete for substrate with pathogenic bacteria, produce bacterio-cins, increase transepithelial resistance. Their enzymatic activity affects activation or deactivation of metabolites which cause diarrhea. Production of short chain fatty acids, which are important for the maintenance of intestinal mucosal cells also contributes to their antidiarrhoeal effect. This randomized, double-blind, placebo controlled, multicentre trial was designed to evaluate potential of probiotics to prevent grade 3-4 diarrhea in patients treated by irinotecan based chemotherapy during first 6 weeks of irinotecan based chemotherapy
Details
| Lead sponsor | S&D Pharma SK s.r.o. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 233 |
| Start date | 2016-03 |
| Completion | 2022-11 |
Conditions
- Diarrhea
- Cancer
Interventions
- Probio-Tec® BG-VCap-6.5
- Placebo
Primary outcomes
- Prevention of grade 3-4 diarrhea induced by irinotecan based chemotherapy — first 6 weeks of irinotecan based chemotherapy
To determine the efficacy (as measured by prevention of grade 3/4 diarrhea) of probiotic formula Probio-Tec® BG-VCap-6.5 given orally to patients with colorectal cancer starting new line of irinotecan based chemotherapy. Response will be defined as prevention of grade 3/4 diarrhea according to definition of NCI CTC version 4.0
Countries
Slovakia