Prevention of Irinotecan Induced Diarrhea by Probiotics

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S&D Pharma SK s.r.o.
• Collaborator: National Cancer Institute, Slovakia
• Treatments: Irinotecan

Criteria

Inclusion Criteria:

• signed written informed consent

• age > 18 years

• histologically proven colorectal cancer patients starting new line of chemotherapy based on irinotecan

• ECOG PS 0 - 1 at study entry

• life expectancy more than 3 months

• absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;

Exclusion Criteria:

• impossibility to take oral medication

• active infection treated by antibiotic therapy

• ileostoma

• hypersensitivity to study drug

• any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years.

• serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator )