Synbiotics and Treatment of Asthma: A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial
DOI:
https://doi.org/10.31661/gmj.v8i.1350Keywords:
Asthma, Synbiotics, Probiotics, Iran, Kidilact®Abstract
Background: We examined the efficiency and safety of a specific synbiotic compound, brand name Kidilact®, in the treatment of asthma in children 12 years of age or younger. Materials and Methods: This double-blinded, randomized, placebo-controlled clinical trial was conducted in Tehran, Iran, from May 22, 2016, to May 21, 2017. One hundred children, 12 years of age or younger, who suffered from mild to moderate asthma were recruited in this study. The subjects were randomly divided into two groups; the experimental group received a sachet of Kidilact®, and the control group received a sachet of placebo once a day for six months. Both groups were compared in terms of the frequency of asthma attacks that were severe enough to require administration of fast-acting medications, the number of outpatient visits for asthma-related problems, and the frequency of hospitalization due to exacerbated symptoms of asthma. Results: There were fewer complaints of drug-induced side effects, e.g., vomiting, headache, stomachache, and diarrhea, exacerbated cough, and constipation in the experimental group than in the control group. Overall, a significantly greater number of participants in the experimental group were satisfied with the therapeutic intervention than those in the control group, as verified by the participants and their parents/guardians self-report. There was no significant difference between both groups in the frequency of asthma attacks and hospitalization due to exacerbated symptoms of asthma. The only significant difference between both groups was the count of outpatient visits. While the control group made 55 outpatient visits to the hospital, participants in the experimental group visited the hospital only 19 times (P=0.001). Conclusion: Results of our study indicates that synbiotic compound Kidilact® generally alleviates the symptoms of asthma in children of 12 years of age or younger, resulting in less frequent outpatient visits to the hospital due to asthma-related problems while rarely causing any side effects. Due to ease of use, the rarity of side effects, and their indirect positive effects on quality of life of asthmatic patients, we recommend that synbiotics be incorporated in regular treatment and management of children with asthma. [GMJ.2019;8:e1350]
References
Ghaffari J, Aarabi M: The prevalence of pediatric asthma in the Islamic Republic of Iran: A systematic review and meta-analysis. J Pediatr Rev. 2013, 1(1):2-11. Sennhauser FH, Braun-Fahrländer C, Wildhaber JH: The burden of asthma in children: a European perspective. Paediatr Respir Rev. 2005, 6(1):2-7. https://doi.org/10.1016/j.prrv.2004.11.001PMid:15698807 Kendig EL, Wilmott RW, Chernick V: Kendig and Chernick's disorders of the respiratory tract in children. Elsevier Health Sciences; 2012. Hassanzad M, Khalilzadeh S, Nobari SE, Bloursaz M, Sharifi H, Mohajerani SA, Nejad ST, Velayati AA: Cotinine level is associated with asthma severity in passive smoker children. Iran J Allergy Asthma Immunol. 2015, 14(1):67-73. Kalliomäki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E: Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001, 357(9262):1076-1079. https://doi.org/10.1016/S0140-6736(00)04259-8 Binns N: Internationsl life sciences institute (ISLI) Europe: concise monograph series. Probiotics, prebiotics and the gut microbiota. In.; 2013. Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S: The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014, 11(8):506-514. https://doi.org/10.1038/nrgastro.2014.66PMid:24912386 Isolauri E, Sütas Y, Kankaanpää P, Arvilommi H, Salminen S: Probiotics: effects on immunity. The American journal of clinical nutrition. 2001, 73(2):444s-450s. https://doi.org/10.1093/ajcn/73.2.444sPMid:11157355 Fouhy F, Guinane CM, Hussey S, Wall R, Ryan CA, Dempsey EM, Murphy B, Ross RP, Fitzgerald GF, Stanton C: High-throughput sequencing reveals the incomplete, short-term recovery of infant gut microbiota following parenteral antibiotic treatment with ampicillin and gentamicin. Antimicrob Agents Chemother. 2012, 56(11):5811-5820. https://doi.org/10.1128/AAC.00789-12PMid:22948872 PMCid:PMC3486619 Rougé C, Goldenberg O, Ferraris L, Berger B, Rochat F, Legrand A, Göbel UB, Vodovar M, Voyer M, Rozé J-C: Investigation of the intestinal microbiota in preterm infants using different methods. Anaerobe. 2010, 16(4):362-370. https://doi.org/10.1016/j.anaerobe.2010.06.002PMid:20541022 Boehm G, Stahl B: Oligosaccharides from milk. J Nutr. 2007, 137(3):847S-849S. https://doi.org/10.1093/jn/137.3.847SPMid:17311985 Nauta AJ, Garssen J: Evidence-based benefits of specific mixtures of non-digestible oligosaccharides on the immune system. Carbohydr Polym. 2013, 93(1):263-265. https://doi.org/10.1016/j.carbpol.2012.02.021PMid:23465928 Knol J, Scholtens P, Kafka C, Steenbakkers J, Gro S, Helm K, Klarczyk M, Schöpfer H, Böckler H-M, Wells J: Colon microflora in infants fed formula with galacto-and fructo-oligosaccharides: more like breast-fed infants. J Pediatr Gastroenterology Nutr. 2005, 40(1):36-42. https://doi.org/10.1097/00005176-200501000-00007 Guinane CM, Cotter PD: Role of the gut microbiota in health and chronic gastrointestinal disease: understanding a hidden metabolic organ. Therap Adv Gastroenterol. 2013, 6(4):295-308. https://doi.org/10.1177/1756283X13482996PMid:23814609 PMCid:PMC3667473 Scholtens PA, Oozeer R, Martin R, Amor KB, Knol J: The early settlers: intestinal microbiology in early life. Ann Rev Food Sci Technol. 2012, 3:425-447. https://doi.org/10.1146/annurev-food-022811-101120PMid:22224552 Masoli M, Fabian d, Holt S, Beasley R: Global initiative for Asthma (GinA) program: the global burden of asthma: executive summary of the GinA dissemination committee report. Allergy. 2004, 59:469-478. https://doi.org/10.1111/j.1398-9995.2004.00526.xPMid:15080825 Aureli P, Capurso L, Castellazzi AM, Clerici M, Giovannini M, Morelli L, Poli A, Pregliasco F, Salvini F, Zuccotti GV: Probiotics and health: an evidence-based review. Pharmacological research. 2011, 63(5):366-376. https://doi.org/10.1016/j.phrs.2011.02.006PMid:21349334 Van der Aa L, Van Aalderen W, Heymans H, Henk Sillevis Smitt J, Nauta A, Knippels L, Ben Amor K, Sprikkelman A, Group SS: Synbiotics prevent asthmaâ€like symptoms in infants with atopic dermatitis. Allergy. 2011, 66(2):170-177. https://doi.org/10.1111/j.1398-9995.2010.02416.xPMid:20560907 Chen YS, Lin YL, Jan RL, Chen HH, Wang JY: Randomized placeboâ€controlled trial of lactobacillus on asthmatic children with allergic rhinitis. Pediatr Pulmonol. 2010, 45(11):1111-1120. https://doi.org/10.1002/ppul.21296PMid:20658483 Rose M, Stieglitz F, Köksal A, Schubert R, Schulze J, Zielen S: Efficacy of probiotic Lactobacillus GG on allergic sensitization and asthma in infants at risk. Clin Exp Allergy. 2010, 40(9):1398-1405. https://doi.org/10.1111/j.1365-2222.2010.03560.xPMid:20604800 Niers L, MartÃn R, Rijkers G, Sengers F, Timmerman H, Van Uden N, Smidt H, Kimpen J, Hoekstra M: The effects of selected probiotic strains on the development of eczema (the PandA study). Allergy. 2009, 64(9):1349-1358. https://doi.org/10.1111/j.1398-9995.2009.02021.xPMid:19392993 Gorissen D, Rutten N, Oostermeijer C, Niers L, Hoekstra M, Rijkers G, Van der Ent C: Preventive effects of selected probiotic strains on the development of asthma and allergic rhinitis in childhood. The Panda study. Clin Exp Allergy. 2014, 44(11):1431-1433. https://doi.org/10.1111/cea.12413PMid:25227163 Williams NT: Probiotics. American Journal of Health-System Pharmacy. 2010, 67(6):449-458. https://doi.org/10.2146/ajhp090168PMid:20208051
