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Prevention of Irinotecan Induced Diarrhea by Probiotics

NCT02819960 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2022-12-14

No results posted yet for this study

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

Conditions

Interventions

DRUG

Probio-Tec® BG-VCap-6.5

Each capsule contents: 2 lyophilized probiotic strains, total amount of minimum 2,7x10 9 CFU/cps, ratio LGG®: BB-12® = 50% : 50% (Culture percentages are based on cell concentration and are approximate) Lactobacillus rhamnosus GG® (ATCC 53103) Bifidobacterium animalis subsp. lactis BB-12® (DSM 15954) Additives: maltodextrin, microcrystalline cellulose, silicium dioxide, magnesium stearate

DRUG

Placebo

Maltodextrin

Sponsors & Collaborators

  • National Cancer Institute, Slovakia

    collaborator OTHER_GOV

  • S&D Pharma SK s.r.o.

    lead INDUSTRY

Principal Investigators

  • Michal Mego, MD · National Cancer Institute Bratislava

  • Lubos Drgona, MD · National Cancer Institute Bratislava

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2022-08-31
Completion
2022-11-30

Countries

  • Slovakia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02819960 on ClinicalTrials.gov