Use of Neoflorum probiotic to prevent gastrointestinal tract damage during antibiotic therapy in children
DOI:
https://doi.org/10.15574/SP.2024.139.7Keywords:
children, antibiotic-associated diarrhea, probiotics, Lactobacillus rhamnosus, Saccharomyces boulardii, Bifidobacterium longum, Lactobacillus helveticus, calprotectinAbstract
The use of antibiotics can affect the resistance of the intestinal microflora, causing digestive disorders and antibiotic-associated diarrhea (AAD). The drug "Neoflorum", which contains Lactobacillus rhamnosus and Saccharomyces boulardii, is a promising combined probiotic for maintaining the health of the intestinal microflora.
The aim of the study is to investigate the effectiveness of the probiotic "Neoflorum" in the prevention of AAD and the safety of the use in children, who are receiving antibiotics because of acute respiratory infection (ARI).
Materials and methods. An open, prospective, non-interventional, comparative study was conducted. 47 children aged 3-13 were examined (average age 6.91±2.87 years). The main group of the study included 25 children who received an antibiotic and a combined probiotic "Neoflorum" in the complex treatment of an ARI. 22 children of control group received an antibiotic without a probiotic.
Results. At the beginning of the study, none of the patients in both groups complained of dyspeptic disorders. Analysis of coprological studies and the level of fecal calprotectin in both groups at the initial stage of treatment did not reveal any pathological changes. AAD developed in 20% of children in the intervention group and 45.5% of children in the control group, which was 2.3 times less. The level of fecal calprotectin was normal in almost all children with AAD (except one child of the control group) on the first day of the diarrhea. 92% of children in the main group noted good tolerance of "Neoflorum", and two children - satisfactory tolerance. There were no side effects while taking "Neoflorum".
Conclusions. In the case of conducting oral antibacterial therapy against the background of the use of the probiotic Neoflorum AAD from the first day of treatment, AAD was detected 2.3 times less often than when conducting antibiotic therapy without the background intake of a probiotic. The use of the Neoflorum probiotic from the first day of antibiotic therapy made it possible to achieve a statistically significant antidiarrheal effect already on the 4-5th day, as indicated by a significantly lower number of children with AAD in the main group - 16% compared to the control group - 45.5%. Good tolerance of "Neoflorum" is noted by 92% of patients.
The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the clinical base. The informed consent of the patient was obtained for conducting the studies.
No conflict of interests was declared by the authors.
References
Abad CLR, Safdar N. (2021). A Review of Clostridioides difficile Infection and Antibiotic-Associated Diarrhea. Gastroenterol Clin North Am. 50(2): 323-340. https://doi.org/10.1016/j.gtc.2021.02.010; PMid:34024444
Alyousef AA. (2018). Clostridium difficile: Epidemiology, Pathogenicity, and an Update on the Limitations of and Challenges in its Diagnosis. J AOAC Int. 101(4): 1119-1126. https://doi.org/10.5740/jaoacint.17-0352; PMid:29229019
Baù M, Moretti A, Bertoni E, Vazzoler V, Luini C, Agosti M, Salvatore S. (2020). Risk and Protective Factors for Gastrointestinal Symptoms associated with Antibiotic Treatment in Children: A Population Study. Pediatr. Gastroenterol. Hepatol. Nutr. 23: 35-48. https://doi.org/10.5223/pghn.2020.23.1.35; PMid:31988874 PMCid:PMC6966223
Czepiel J et al. (2019). Clostridium difficile infection: review. Eur J Clin Microbiol Infect Dis. 38(7): 1211-1221. https://doi.org/10.1007/s10096-019-03539-6; PMid:30945014 PMCid:PMC6570665
Guo Q, Goldenberg JZ, Humphrey C, El Dib R, Johnston BC. (2019). Probiotics for the prevention of pediatric antibiotic-associated diarrhea. Cochrane Database Syst Rev. 4(4): CD004827. https://doi.org/10.1002/14651858.CD004827.pub5
Havelka A, Larsson AO, Mårtensson J, Bell M, Hultström M, Lipcsey M, Eriksson M. (2023). Analysis of Calprotectin as an Early Marker of Infections Is Economically Advantageous in Intensive Care-Treated Patients. Biomedicines. 11(8): 2156. https://doi.org/10.3390/biomedicines11082156; PMid:37626653 PMCid:PMC10452832
Hojsak I, Kolaček S. (2024). Role of Probiotics in the Treatment and Prevention of Common Gastrointestinal Conditions in Children. Pediatr Gastroenterol Hepatol Nutr. 27(1): 1-14. https://doi.org/10.5223/pghn.2024.27.1.1; PMid:38249642 PMCid:PMC10796258
Huang H, Li L, Wu M, Liu Z, Zhao Y, Peng J, Ren X, Chen S. (2023). Antibiotics and antibiotic-associated diarrhea: a real-world disproportionality study of the FDA adverse event reporting system from 2004 to 2022. BMC Pharmacol Toxicol. 24(1): 73. https://doi.org/10.1186/s40360-023-00710-w; PMid:38049920 PMCid:PMC10694877
Ivanko OH, Bondarenko VM. (2021). Klasternyi analiz prychyn hostrykh diarei u ditei rannoho viku, hospitalizovanykh v infektsiine viddilennia. Patolohiia. 18(2): 196-202. https://doi.org/10.14739/2310-1237.2021.2.229500
Kolho KL, Alfthan H. (2020). Concentration of fecal calprotectin in 11,255 children aged 0-18 years. Scandinavian journal of gastroenterology. 55(9): 1024-1027. https://doi.org/10.1080/00365521.2020.1794026; PMid:32672082
Kuzenko YuH. (2021). Porivniannia efektyvnosti riznykh probiotykiv u razi postinfektsiinoho syndromu podraznenoi kyshky. Medychna hazeta "Zdorov'ia Ukrainy 21 storichchia". 8(511): 49-50.
Larcombe S, Hutton ML, Lyras D. (2016). Involvement of Bacteria Other Than Clostridium difficile in Antibiotic-Associated Diarrhoea. Trends Microbiol. 24(6): 463-476. https://doi.org/10.1016/j.tim.2016.02.001; PMid:26897710
Litao G et al. (2018). Risk Factors for Antibiotic-Associated Diarrhea in Critically Ill Patients. Med Sci Monit. 24: 5000-5007. https://doi.org/10.12659/MSM.911308; PMid:30020891 PMCid:PMC6067053
Marushko YuV, Hyshchak TV, Chabanovych OV. (2021). Osnovni mekhanizmy vplyvu kyshkovoi mikroflory na imunnu systemu ta yikh znachennia v klinichnii praktytsi. Simeina medytsyna. 4: 19-27. https://doi.org/10.30841/2307-5112.4.2021.249409
Marushko YuV, Hyshchak TV, Pysariev AO, Iovitsa TV. (2023). Zastosuvannia Saccharomyces boulardii dlia poperedzhennia antybiotykoasotsiiovanoi diarei u ditei z pnevmoniieiu ta bronkhitom. Simeina Medytsyna. Yevropeiski praktyky. 3: 55-62. https://doi.org/10.30841/2786-720X.3.2023.289354
Marushko YuV, Hyshchak TV, Todyka YuA. (2021). Profilaktychnyi efekt probiotychnoho vtruchannia u ditei, skhylnykh do hostrykh infektsii verkhnikh dykhalnykh shliakhiv: randomizovane kontrolovane doslidzhennia. Medychna nauka Ukrainy (MDU). 17(3): 51-65. https://doi.org/10.32345/2664-4738.3.2021.06
Marushko Yu, Moskovenko O. (2018). Efektyvnist i bezpeka zastosuvannia Saccharomyces boulardii u klinichnii praktytsi. Pediatria. 3(46): 37-38.
Nasiri MJ et al. (2018). Clostridioides (Clostridium) difficile infection in hospitalized patients with antibiotic-associated diarrhea: A systematic review and meta-analysis. Anaerobe. 50: 32-37. https://doi.org/10.1016/j.anaerobe.2018.01.011; PMid:29408016
Nasiri MJ, Goudarzi M, Hajikhani B, Ghazi M, Goudarzi H, Pouriran R. (2018). Clostridioides (Clostridium) difficile infection in hospitalized patients with antibiotic-associated diarrhea: A systematic review and meta-analysis. Anaerobe. 50: 32-37. https://doi.org/10.1016/j.anaerobe.2018.01.011; PMid:29408016
Rinninella E, Raoul P, Cintoni M, Franceschi F, Miggiano GAD, Gasbarrini A, Mele MC. (2019). What is the Healthy Gut Microbiota Composition? A Changing Ecosystem across Age, Environment, Diet, and Diseases. Microorganisms. 7: 14. https://doi.org/10.3390/microorganisms7010014; PMid:30634578 PMCid:PMC6351938
Salvatore S, Pensabene L, Borrelli O, Saps M, Thapar N, Concolino D, Staiano A, Vandenplas Y. (2018). Mind the gut: Probiotics in paediatric neurogastroenterology. Beneficial microbes. 9(6): 883-898. https://doi.org/10.3920/BM2018.0013; PMid:30198327
Saviano A, Petruzziello C, Cancro C, Macerola N, Petti A, Nuzzo E et al. (2024). The Efficacy of a Mix of Probiotics (Limosilactobacillus reuteri LMG P-27481 and Lacticaseibacillus rhamnosus GG ATCC 53103) in Preventing Antibiotic-Associated Diarrhea and Clostridium difficile Infection in Hospitalized Patients: Single-Center, Open-Label, Randomized Trial. Microorganisms. 12(1): 198. https://doi.org/10.3390/microorganisms12010198; PMid:38258024 PMCid:PMC10819176
Storr M, Stengel A. (2021). Klinische Evidenz zu Probiotika in der Prävention einer Antibiotika-assoziierten Diarrhö : Systematischer Review [Systematic review: clinical evidence of probiotics in the prevention of antibiotic-associated diarrhoea]. MMW Fortschritte der Medizin. 163(4): 19-26. https://doi.org/10.1007/s15006-021-9762-5; PMid:33844181
Suetens C, Latour K, Kärki T, Ricchizzi E, Kinross P, Moro ML et al. (2018). Prevalence of healthcare-associated infections, estimated incidence and composite antimicrobial resistance index in acute care hospitals and long-term care facilities: results from two European point prevalence surveys, 2016 to 2017. Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin. 23(46): 1800516. https://doi.org/10.2807/1560-7917.ES.2018.23.46.1800516
Szajewska H, Canani RB, Domellöf M, Guarino A, Hojsak I, Indrio F et al. (2023). Probiotics for the Management of Pediatric Gastrointestinal Disorders: Position Paper of the ESPGHAN Special Interest Group on Gut Microbiota and Modifications. Journal of pediatric gastroenterology and nutrition. 76(2): 232-247. https://doi.org/10.1097/MPG.0000000000003633; PMid:36219218
Szajewska H, Canani RB, Guarino A, Hojsak I, Indrio F, Kolacek S et al. (2016). Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Children. Journal of pediatric gastroenterology and nutrition. 62(3): 495-506. https://doi.org/10.1097/MPG.0000000000001081; PMid:26756877
Thursby E, Juge N. (2017). Introduction to the human gut microbiota. The Biochemical journal. 474(11): 1823-1836. https://doi.org/10.1042/BCJ20160510; PMid:28512250 PMCid:PMC5433529
Tsiupa I. (2020). Saccharomyces boulardii - probiotyk, yakomu mozhna doviriaty. Zdorovya Ukrainy. 2(53): 18-19.
Urbańska M, Szajewska H. (2014). The efficacy of Lactobacillus reuteri DSM 17938 in infants and children: A review of the current evidence. European journal of pediatrics. 173(10): 1327-1337. https://doi.org/10.1007/s00431-014-2328-0; PMid:24819885 PMCid:PMC4165878
Walsham NE, Sherwood RA. (2016). Fecal calprotectin in inflammatory bowel disease. Clinical and experimental gastroenterology. 2016(9): 21-29. https://doi.org/10.2147/CEG.S51902; PMid:26869808 PMCid:PMC4734737
Wan CM, Yu H, Liu G, Xu HM, Mao ZQ, Xu Y et al. (2017). A multicenter randomized controlled study of Saccharomyces boulardii in the prevention of antibiotic-associated diarrhea in infants and young children. Zhonghua Er Ke Za Zhi. 55(5): 349-354. Chinese. doi: 10.3760/cma.j.issn.0578-1310.2017.05.008.
Wilkins T, Sequoia J. (2017). Probiotics for Gastrointestinal Conditions: A Summary of the Evidence. American family physician. 96(3): 170-178.
Zhang J, Wan S, Gui Q. (2021). Comparison of safety, effectiveness and serum inflammatory factor indexes of Saccharomyces boulardii versus Bifidobacterium triple viable in treating children with chronic diarrhea: a randomized trial. Transl Pediatr. 10(6): 1677-1685. https://doi.org/10.21037/tp-21-195; PMid:34295782 PMCid:PMC8261597
Zhang Y et al. (2018). Enzyme Inhibitor Antibiotics and Antibiotic-Associated Diarrhea in Critically Ill Patients. Med Sci Monit. 24: 8781-8788. https://doi.org/10.12659/MSM.913739; PMid:30512009 PMCid:PMC6289033
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