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Prevention of Febrile Neutropenia in Pediatric Cancer Patients by Lactobacillus Rhamnosus GG and Bifidobacterium Animalis Subspecies. Lactis BB-12 in Combination With Inulin and Oligofructose (FENSY)
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.
Details
| Lead sponsor | S&D Pharma SK s.r.o. |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2010-07 |
| Completion | 2019-10 |
Conditions
- Febrile Neutropenia
- Neutropenia
- Infection in an Immunocompromised Host
- Cancer
Interventions
- Probio-Fix Inum
- Beneo Synergy 1
- Placebo
Primary outcomes
- Reduction in the incidence of febrile neutropenia episodes — 3 months
Febrile neutropenia is defined as an oral temperature \>38.3°C or two consecutive readings of \>38.0°C sustained for more than 1 hour and an absolute neutrophil count \<0.5 × 109/l, or expected to fall below 0.5 × 109/l in the next 48-hour period
Countries
Slovakia