Clinical trial · Interventional
Prevention of Febrile Neutropenia by Synbiotics in Pediatric Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Infection in an Immunocompromised Host | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Beneo Synergy 1 | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Probio-Fix Inum | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Synbiotics group
- description
- 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
- interventionNames
- Dietary Supplement: Probio-Fix Inum
- Dietary Supplement: Beneo Synergy 1
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Interventions: administration of placebo Start: 5 days before or 2 days after starting chemotherapy Duration: 3 months
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Reduction in the incidence of febrile neutropenia episodes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 19 Years
Show eligibility criteria text
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
References
Publications (65)
- BACKGROUNDCole GT, Halawa AA, Anaissie EJ. The role of the gastrointestinal tract in hematogenous candidiasis: from the laboratory to the bedside. Clin Infect Dis. 1996 May;22 Suppl 2:S73-88. doi: 10.1093/clinids/22.supplement_2.s73. PMID 8722833
- BACKGROUNDKlastersky J. A review of chemoprophylaxis and therapy of bacterial infections in neutropenic patients. Diagn Microbiol Infect Dis. 1989 Jul-Aug;12(4 Suppl):201S-207S. doi: 10.1016/0732-8893(89)90137-5. PMID 2686921
- BACKGROUNDMarshall JC. Gastrointestinal flora and its alterations in critical illness. Curr Opin Clin Nutr Metab Care. 1999 Sep;2(5):405-11. doi: 10.1097/00075197-199909000-00009. PMID 10589383
- BACKGROUNDSchimpff SC, Young VM, Greene WH, Vermeulen GD, Moody MR, Wiernik PH. Origin of infection in acute nonlymphocytic leukemia. Significance of hospital acquisition of potential pathogens. Ann Intern Med. 1972 Nov;77(5):707-14. doi: 10.7326/0003-4819-77-5-707. No abstract available. PMID 4628214
- BACKGROUNDSalva S, Marranzino G, Villena J, Aguero G, Alvarez S. Probiotic Lactobacillus strains protect against myelosuppression and immunosuppression in cyclophosphamide-treated mice. Int Immunopharmacol. 2014 Sep;22(1):209-21. doi: 10.1016/j.intimp.2014.06.017. Epub 2014 Jun 24. PMID 24975836
- BACKGROUNDSatonaka K, Ohashi K, Nohmi T, Yamamoto T, Abe S, Uchida K, Yamaguchi H. Prophylactic effect of Enterococcus faecalis FK-23 preparation on experimental candidiasis in mice. Microbiol Immunol. 1996;40(3):217-22. doi: 10.1111/j.1348-0421.1996.tb03337.x. PMID 8934676
- BACKGROUNDShida K, Nomoto K. Probiotics as efficient immunopotentiators: translational role in cancer prevention. Indian J Med Res. 2013 Nov;138(5):808-14. PMID 24434333