Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients

Summary

Febrile neutropenia (FN) is a major life-threatening treatment complication in cancer patients undergoing intensive chemotherapy. Endogenous flora is considered to be one of the main sources of infections during neutropenia. Competitive inhibition of gut mucosal colonization by pathogenic microorganisms using synbiotics could represent one of the potential options for its prevention. Synbiotics represent combination of two components: probiotics and prebiotics. Probiotics are live microorganisms, which in form of drugs or food supplements administered at a sufficient dose help to maintain health beneficial microbial balance in the digestive tract of a human or other host. Prebiotics are food ingredients nondigestible for our digestive enzymes, but can be fermented by bacteria in our bowel and this way selectively stimulate growth or activity of specific saccharolytic bacterial strains. These changes in composition of our microflora may bring benefits on host well-being and health. Based on the results of human and animal studies, probiotics probably can not only decrease the level of gut colonisation with pathogenic bacteria, but may also lead to reduction in the duration of neutropenia, accelerate the restitution of the intestinal mucosa and boost immunity. Despite a significant number of studies on probiotics still only little evidence of their safety especially in immunocompromised patients is available.

To help find new options for increasing quality of healthcare for children cancer patients and also to evaluate safety of this new approach investigators designed double-blinded placebo controled multicenter study aimed to decrease the number of febrile episodes using prevention with synbiotic.

Conditions

• Febrile Neutropenia
• Neutropenia
• Infection in an Immunocompromised Host
• Cancer

Interventions

DIETARY_SUPPLEMENT

Probio-Fix Inum

Dose of Probio-Fix Inum: 1 capsule daily first 14 days + 1 capsule twice daily for the rest of prophylaxis duration Probio-Fix Inum: each capsule contains 2.7 billion lyophilized probiotic bacteria Lactobacillus rhamnosus GG, LGG, American Type Culture Collection (ATCC) 53103 and Bifidobacterium animalis subspecies. lactis BB-12 Chr. Hansen Beneo Synergy 1: oligofructose-enriched inulin

DIETARY_SUPPLEMENT

Beneo Synergy 1

Dose of Beneo Synergy 1: depends on the age of the patient (full dose variation: 0,2g/100ml milk formula - 12g/daily), gradually increased as tolerated by the patient every 2-3 days in first 8-12 days

OTHER

Placebo

Same dosage regimen as active drugs

Sponsors & Collaborators

• S&D Pharma SK s.r.o.

  lead INDUSTRY

Principal Investigators

• Vladimir Holec, MD, PhD · University Children's Hospital Banska Bystrica

• Michal Mego, MD, PhD · Comenius University and National Cancer Institute

• Pavel Bician, MD · University Children's Hospital Banska Bystrica

• Vladimir Zajac, RNDr · Slovak Academy of Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2019-09-30

Completion

2019-10-31

Countries

• Slovakia

Study Locations