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Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients (FENSY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02544685
Recruitment Status : Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : January 17, 2019
Information provided by (Responsible Party):
S&D Pharma SK s.r.o.

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.

Condition or disease Intervention/treatment Phase
Febrile Neutropenia Neutropenia Infection in an Immunocompromised Host Cancer Dietary Supplement: Probio-Fix Inum Dietary Supplement: Beneo Synergy 1 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2010
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Active Comparator: Synbiotics group

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

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

Placebo Comparator: Placebo group

Interventions: administration of placebo

Start: 5 days before or 2 days after starting chemotherapy

Duration: 3 months

Other: Placebo
Same dosage regimen as active drugs

Primary Outcome Measures :
  1. Reduction in the incidence of febrile neutropenia episodes [ Time Frame: 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

Secondary Outcome Measures :
  1. Safety evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: 3 months ]
    Safety will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  2. Reduction of the total duration of febrile neutropenia [ Time Frame: 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

  3. Time period to first febrile episode [ Time Frame: 3 months ]
  4. Reduction in the number of septic complications requiring intensive care [ Time Frame: 3 months ]
  5. Reduction in the number of infectious episodes outside the period of neutropenia [ Time Frame: 3 months ]
  6. Reduction in the incidence of diarrhea and enterocolitis episodes related to chemotherapy [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02544685

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University Children's Hospital Banska Bystrica
Banska Bystrica, Slovakia, 97409
Sponsors and Collaborators
S&D Pharma SK s.r.o.
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Principal Investigator: Vladimir Holec, MD, PhD University Children's Hospital Banska Bystrica
Principal Investigator: Michal Mego, MD, PhD Comenius University and National Cancer Institute
Study Chair: Pavel Bician, MD University Children's Hospital Banska Bystrica
Study Chair: Vladimir Zajac, RNDr Slovak Academy of Sciences

Schimpff SC, Young VM, Green WH et al. Origin of infection in acute lymphocytic leukemia: significance of hospital aquisition of potential pathogens. Ann Intern Med 1972; 77:707 In: De Vita,V.T. (Ed): Cancer principles and practice of oncology. Philadelphia, J.B.Lippincott 2000; 2820.
Ishiwa H, Iwata S. Drug resistance plasmids in Lactobacillus fermetum. J Gen Appl Microbiol 1980; 26:71—4.
Morelli L, Wright AV. Probiotic bacteria and transferable antibiotic resistance-safety aspects. Demonstration of the Nutritional Functionality of Probiotic Foods News Letter 1997; 2:9—14.
Gasser S. Safety of lactic acid bacteria and their occurrence in human clinical infection. Bull Inst Pasteur 1994; 92:45—67.
Berg RD. Translocation and the indigenous gut flora. In: FullerR, editor. Probiotics: the scientific basis. London: Chapman &Hall 1992; 55—85.83.

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Responsible Party: S&D Pharma SK s.r.o. Identifier: NCT02544685    
Other Study ID Numbers: 1
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Keywords provided by S&D Pharma SK s.r.o.:
Febrile neutropenia
Additional relevant MeSH terms:
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Febrile Neutropenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms