Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients

NCT02544685 | Unknown Phase 2

• 1 other identifier: 1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Febrile neutropenia; Synbiotic; Probiotic; Prebiotic; Safety; Cancer; Oncology; Chemotherapy; Symbiotic

Outcome Measures

Primary Outcomes (1)

• Reduction in the incidence of febrile neutropenia episodes

  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

  3 months

Secondary Outcomes (6)

• Safety evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  3 months

• Reduction of the total duration of febrile neutropenia

  3 months

• Time period to first febrile episode

  3 months

• Reduction in the number of septic complications requiring intensive care

  3 months

• Reduction in the number of infectious episodes outside the period of neutropenia

  3 months

Study Arms (2)

Synbiotics group

ACTIVE COMPARATOR

Interventions: administration of Probio-Fix Inum + Beneo Synergy 1 Start of prophylaxis: 5 days before or 2 days after starting chemotherapy Prophylaxis duration: 3 months

Dietary Supplement: Probio-Fix Inum; Dietary Supplement: Beneo Synergy 1

Placebo group

PLACEBO COMPARATOR

Interventions: administration of placebo Start: 5 days before or 2 days after starting chemotherapy Duration: 3 months

Other: Placebo

Interventions

Probio-Fix Inum DIETARY_SUPPLEMENT

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

Synbiotics group

Beneo Synergy 1 DIETARY_SUPPLEMENT

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

Synbiotics group

Placebo OTHER

Same dosage regimen as active drugs

Placebo group

Eligibility Criteria

• Age: 6 Months - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• newly diagnosed cancer disease prior to initiation of chemotherapy
• Eastern Cooperative Oncology Group performance status = 0-1
• informed consent has to be given by patients, respectively their legal representatives
• age between 6 months to 19 years
• must be afebrile and no other signs of infection at least 24 hours before starting of prophylaxis
• must not taking other probiotic or prebiotic preparations or discontinued their use more than 14 days ago

You may not qualify if:

• impossibility of oral intake
• receiving any other type of experimental prophylaxis
• estimated survival time of less than 4 weeks
• allogeneic or autologous bone marrow transplantation
• inflammatory bowel disease

Sponsors & Collaborators

• S&D Pharma SK s.r.o.: lead

Study Sites (1)

University Children's Hospital Banska Bystrica

Banská Bystrica, 97409, Slovakia

Location

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MeSH Terms

Conditions

Febrile Neutropenia; Neutropenia; Neoplasms

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Vladimir Holec, MD, PhD

  University Children's Hospital Banska Bystrica

  PRINCIPAL INVESTIGATOR

• Michal Mego, MD, PhD

  Comenius University and National Cancer Institute

  PRINCIPAL INVESTIGATOR

• Pavel Bician, MD

  University Children's Hospital Banska Bystrica

  STUDY CHAIR

• Vladimir Zajac, RNDr

  Slovak Academy of Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2015
• First Posted: September 9, 2015
• Study Start: July 1, 2010
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 17, 2019

Record last verified: 2019-01

Locations

SL (1)