Volume 32, Issue 2 (Avicenna Journal of Clinical Medicine-Summer 2025)
Avicenna J Clin Med 2025, 32(2): 95-101 |
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Kalvandi G, Malekshahi A, Dara N, Shiehmorteza M, Andarzbakhsh K, Kalvandi H. The Efficacy of Lactobacillus reuteri Probiotic in the Treatment of Functional Abdominal Pain in Children Aged 5 to 15 Years. Avicenna J Clin Med 2025; 32 (2) :95-101
URL: http://sjh.umsha.ac.ir/article-1-3245-en.html
URL: http://sjh.umsha.ac.ir/article-1-3245-en.html
Gholamreza Kalvandi1 
, Ahmadreza Malekshahi2 , Naghi Dara3 , Maryam Shiehmorteza4 , Kamyab Andarzbakhsh5 , Hosein Kalvandi6
, Ahmadreza Malekshahi2 , Naghi Dara3 , Maryam Shiehmorteza4 , Kamyab Andarzbakhsh5 , Hosein Kalvandi6
1- Department of Pediatrics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
2- Department of Clinical Pharmacy, Faculty of Pharmacy, Islamic Azad University, Tehran Medical Sciences, Tehran, Iran ,ahmadreza77mk@gmail.com
3- Pediatric Gastroenterology, Hepatology, and Nutrition Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4- Department of Clinical Pharmacy, Pharmaceutical Science Branche, Islamic Azad University, Tehran, Iran
5- Department of Clinical Pharmacy, Faculty of Pharmacy, Islamic Azad University, Tehran Medical Sciences, Tehran, Iran
6- Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
2- Department of Clinical Pharmacy, Faculty of Pharmacy, Islamic Azad University, Tehran Medical Sciences, Tehran, Iran ,
3- Pediatric Gastroenterology, Hepatology, and Nutrition Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran
4- Department of Clinical Pharmacy, Pharmaceutical Science Branche, Islamic Azad University, Tehran, Iran
5- Department of Clinical Pharmacy, Faculty of Pharmacy, Islamic Azad University, Tehran Medical Sciences, Tehran, Iran
6- Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
Abstract: (134 Views)
Background and Objective: Functional abdominal pain disorders are pediatric gastrointestinal diseases characterized by chronic or recurrent abdominal pain without anatomical and/or biochemical abnormalities. The aim of the present study was to investigate the efficacy of the probiotic Lactobacillus reuteri versus placebo in the treatment of functional abdominal pain in children.
Materials and Methods: This randomized clinical trial study was conducted on 180 children aged 5 to 15 years with functional abdominal pain based on Rome IV criteria referred to the pediatric gastroenterology clinics of Mofid Hospital in Tehran and Besat Hospital in Hamadan, Iran. The children were randomly divided into two intervention and placebo groups. The intervention group received Roteflor probiotic sachets and the placebo group received sachets containing inactive ingredients in the same packaging daily for 4 weeks. The severity of abdominal pain and the number of pain episodes during treatment were assessed and recorded weekly by the parents based on the Oucher Pain Scale. Finally, the data between the two groups were compared using SPSS version 26 software.
Results: There was no significant difference in the distribution of age, gender, type of delivery, and family history of disease in the intervention and placebo groups. Pain intensity in the intervention group decreased significantly during treatment (P<0.05), but in the placebo group, the decrease in pain intensity was not significant. Pain intensity in the first to third weeks in the intervention group was less than in the placebo group, but the difference between the two groups was not statistically significant. In the fourth week, pain intensity in the intervention group was significantly less than in the placebo group (P=0.031). The average number of abdominal pain episodes in both groups decreased significantly during treatment (P<0.05). The mean number of pain episodes during treatment in the intervention group was significantly less than in the placebo group (P<0.05).
Conclusion: The results showed that the probiotic Lactobacillus reuteri significantly reduced the severity and frequency of abdominal pain in children with functional abdominal pain compared to placebo. Therefore, the probiotic Lactobacillus reuteri can be recommended as an appropriate control and treatment method in these children
Materials and Methods: This randomized clinical trial study was conducted on 180 children aged 5 to 15 years with functional abdominal pain based on Rome IV criteria referred to the pediatric gastroenterology clinics of Mofid Hospital in Tehran and Besat Hospital in Hamadan, Iran. The children were randomly divided into two intervention and placebo groups. The intervention group received Roteflor probiotic sachets and the placebo group received sachets containing inactive ingredients in the same packaging daily for 4 weeks. The severity of abdominal pain and the number of pain episodes during treatment were assessed and recorded weekly by the parents based on the Oucher Pain Scale. Finally, the data between the two groups were compared using SPSS version 26 software.
Results: There was no significant difference in the distribution of age, gender, type of delivery, and family history of disease in the intervention and placebo groups. Pain intensity in the intervention group decreased significantly during treatment (P<0.05), but in the placebo group, the decrease in pain intensity was not significant. Pain intensity in the first to third weeks in the intervention group was less than in the placebo group, but the difference between the two groups was not statistically significant. In the fourth week, pain intensity in the intervention group was significantly less than in the placebo group (P=0.031). The average number of abdominal pain episodes in both groups decreased significantly during treatment (P<0.05). The mean number of pain episodes during treatment in the intervention group was significantly less than in the placebo group (P<0.05).
Conclusion: The results showed that the probiotic Lactobacillus reuteri significantly reduced the severity and frequency of abdominal pain in children with functional abdominal pain compared to placebo. Therefore, the probiotic Lactobacillus reuteri can be recommended as an appropriate control and treatment method in these children
Type of Study: Original |
Subject:
Pediatrics (all specialties)
Extended Abstract [HTML 28 KB] (12 Download)
References
1. Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, et al. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006;130(5):1527-37. PMID: 16678566 DOI: 10.1053/j.gastro.2005.08.063
2. Korterink JJ, Diederen K, Benninga MA, Tabbers MM. Epidemiology of pediatric functional abdominal pain disorders: a meta-analysis. PLoS One. 2015;10(5):e0126982. PMID: 25992621 DOI: 10.1371/journal.pone.0126982
3. Spee LA, Lisman-Van Leeuwen Y, Benninga MA, Bierma-Zeinstra SM, Berger MY. Prevalence, characteristics, and management of childhood functional abdominal pain in general practice. Scand J Prim Health Care. 2013;31(4):197-202. PMID: 24106821 DOI: 10.3109/02813432.2013.844405
4. Bao X, Yu W, Chu Z, Gao J, Zhou M, Gu Y. Functional abdominal pain disorders in children in southern Anhui Province, China are related to academic stress rather than academic performance. BMC Pediatr. 2023;23(1):333. DOI:10.1186/s12887-023-04154-3
5. Olafsdottir E, Gilja OH, Aslaksen A, Berstad A, Fluge G. Impaired accommodation of the proximal stomach in children with recurrent abdominal pain. J Pediatr Gastroenterol Nutr. 2000;30:157. PMID: 10697134 DOI: 10.1097/00005176-200002000-00012
6. Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2016;150(6):1456-68. PMID: 27144632 DOI: 10.1053/j.gastro.2016.02.015
7. Hoekman DR, Rutten JMTM, Vlieger AM, Benninga MA, Dijkgraaf MGW. Annual costs of care for pediatric irritable bowel syndrome, functional abdominal pain, and functional abdominal pain syndrome. J Pediatr. 2015;167:1103-8. PMID: 26329806 DOI: 10.1016/j.jpeds.2015.07.058
8. Chelimsky G, Boyle JT, Tusing L, Chelimsky TC. Autonomic abnormalities in children with functional abdominal pain: coincidence or etiology? J Pediatr Gastroenterol Nutr. 2001;33)1):47-53. PMID: 11479407 DOI: 10.1097/00005176-200107000-00008
9. Newlove‐Delgado TV, Martin AE, Abbott RA, Bethel A, Thompson‐Coon J, Whear R, et al. Dietary interventions for recurrent abdominal pain in childhood. Cochrane Database Syst Rev. 2017;2017(3). PMID: 28334433 DOI: 10.1002/14651858.CD010972.pub2
10. Trivić I, Niseteo T, Jadrešin O, Hojsak I. Use of probiotics in the treatment of functional abdominal pain in children—systematic review and meta-analysis. Eur J Pediatr. 2021;180(2):339-51. PMID: 32940743 DOI: 10.1007/s00431-020-03809-y
11. Weizman Z, Abu-Abed J, Binsztok M. Lactobacillus reuteri DSM 17938 for the management of functional abdominal pain in childhood: a randomized, double-blind, placebo-controlled trial. J Ppediatr. 2016;174:160-4. e1. PMID: 27156182 DOI: 10.1016/j.jpeds.2016.04.003
12. Suez J, Zmora N, Segal E, Elinav E. The pros, cons, and many unknowns of probiotics. Nat Med. 2019;25(5):716-29. PMID: 31061539 DOI: 10.1038/s41591-019-0439-x
13. Wegh CA, Benninga MA, Tabbers MM. Effectiveness of probiotics in children with functional abdominal pain disorders and functional constipation: a systematic review. J Clin Gastroenterol. 2018;52:S10-26. PMID: 29782469 DOI: 10.1097/MCG.0000000000001054
14. Gwee KA, Lee WR, Chua Q, Chiou FK, Aw MM, Koh YH. The evidence for probiotics in the treatment of digestive disorders in the pediatric population. J Gastroenterol Hepatol. 2025;40(1):41-7. PMID: 39542020 DOI: 10.1111/jgh.16809
15. Hojsak I. Probiotics in functional gastrointestinal disorders. In: Guandalini S, Indrio F. (eds) Probiotics and Child Gastrointestinal Health: Advances in Microbiology, Infectious Diseases and Public Health Volume 10. Springer, Cham; 2018:121-37. DOI:10.1007/5584_2018_321
16. Pärtty A, Rautava S, Kalliomäki M. Probiotics on pediatric functional gastrointestinal disorders. Nutrients. 2018;10(12):1836. PMID: 30501103 DOI: 10.3390/nu10121836
17. Jadrešin O, Sila S, Trivić I, Mišak Z, Kolaček S, Hojsak I. Lactobacillus reuteri DSM 17938 is effective in the treatment of functional abdominal pain in children: Results of the double-blind randomized study. Clin Nutr. 2020;39(12):3645-51. PMID: 32362486 DOI: 10.1016/j.clnu.2020.04.019
18. Romano C, Ferrau' V, Cavataio F, Iacono G, Spina M, Lionetti E, et al. Lactobacillus reuteri in children with functional abdominal pain (FAP). J Paediatr Child Health. 2014;50(10):E68-E71. PMID: 20626584 DOI: 10.1111/j.1440-1754.2010.01797.x
19. Eftekhari K, Vahedi Z, Aghdam MK, Diaz DN. A randomized double-blind placebo-controlled trial of Lactobacillus reuteri for chronic functional abdominal pain in children. Iran J Pediatr. 2015;25(6). PMID: 26635937 DOI: 10.5812/ijp.2616
20. Maragkoudaki M, Chouliaras G, Orel R, Horvath A, Szajewska H, Papadopoulou A. Lactobacillus reuteri DSM 17938 and a placebo both significantly reduced symptoms in children with functional abdominal pain. Acta Paediatrica. 2017;106(11):1857-62. PMID: 28712129 DOI: 10.1111/apa.13992
21. Rahmani P, Ghouran-orimi A, Motamed F, Moradzadeh A. Evaluating the effects of probiotics in pediatrics with recurrent abdominal pain. Clin ExpPediatr. 2020;63:485-90. PMID: 32718147 DOI: 10.3345/cep.2019.01613
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