Efficacy and Safety of Saccharomyces boulardii in Acute Childhood Diarrhea: A Double Blind Randomised Controlled Trial
Abstract
Objective To see the efficacy and safety of 250 mg of Saccharomyces boulardii twice daily for 5 d in acute childhood diarrhea.Methods Children aged between 3 mo and 59 mo with acute onset diarrhea (of less than 48 h) admitted in DTTU (diarrhea treatment and training unit) were included and those with clinical evidence of severe malnutrition, systemic infection, encephalopathy and/or convulsion, electrolyte imbalance, invasive diarrhea or previous use of any probiotics were excluded from the study. Those included randomly were given either a placebo or Saccharomyces boullardi (SB) in identical packets mixed with puffed rice powder.Results Mean post intervention duration of diarrhea was significantly (95% CI = -28.13 to -5.43) shorter in SB group (52.08 ± 24.57 h) as compared to placebo group (64.04 ± 30.43 h). The time of appearance of first semi formed stool in SB group (39.48 ± 23.09 h) was significantly (95% CI -25.4 to -3.87) shorter than the placebo group (54.13 ± 28.21 h). No statistically significant difference was found in rest of the parameters.Conclusions There is initial evidence available that SB may have a therapeutic role in the management of acute childhood diarrhea.
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Clinical trials support the efficacy of S. boulardii in reducing the duration and severity of acute diarrhea, especially in pediatric populations.
“Clinical trials supports its efficacy in reducing the duration and severity of acute diarrhea (e.g., NCT03539913), especially in pediatric populations.9”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [9]
S. boulardii-based products lacked detectable ARGs or virulence factors while exhibiting intrinsic, non-transferable antibiotic resistance, supporting a comparatively favorable safety profile in high-risk clinical settings.
“In contrast to bacterial probiotics, S. boulardii–based products lacked detectable ARGs or virulence factors while exhibiting intrinsic, non-transferable antibiotic resistance, supporting a comparatively favorable safety profile in high-risk clinical settings.4,9,36,37”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [9]
Clinical studies have previously established S. boulardii's efficacy in reducing diarrhea duration in pediatric and adult populations, particularly in the context of antibiotic-associated diarrhea, Helicobacter pylori, and Clostridioides difficile infections.
“Clinical studies have previously established S. boulardii's efficacy in reducing diarrhea duration in pediatric and adult populations, particularly in the context of AAD, Helicobacter pylori, and Clostridioides difficile infections.9,36,37”
From Safety and efficacy concerns in Indian probiotics: Insights from whole-genome sequencing and <i>in vitro</i> assessment (2026) · cites this paper as [9]
Cites
The global burden of diarrhoeal disease, as estimated from studies published between 1992 and 2000.
Kosek, M. N., Bern, C., & Guerrant, R. L. (2003) · Europe PMC (PubMed Central) · Cited by 1,617 · see citing works
LactobacillusTherapy for Acute Infectious Diarrhea in Children: A Meta-analysis
Niel, C. W. V., Feudtner, C., Garrison, M. M., & Christakis, D. (2002) · PEDIATRICS · doi:10.1542/peds.109.4.678 · Cited by 599 · see citing works
Efficacy of Probiotic Use in Acute Diarrhea in Children: A Meta-Analysis
Huang, J. S., Bousvaros, A., Lee, J. W., Díaz, Á., & Davidson, E. J. (2002) · Digestive Diseases and Sciences · doi:10.1023/a:1020501202369 · Cited by 321 · see citing works
A millennium update on pediatric diarrheal illness in the developing world.
O’Ryan, M., Prado, V., & Pickering, L. K. (2005) · Seminars in Pediatric Infectious Diseases · doi:10.1053/j.spid.2005.12.008 · Cited by 283 · see citing works
Effects of Saccharomyces boulardii in children with acute diarrhoea
Kurugöl, Z., & Koturoğlu, G. (2005) · Acta Paediatrica · doi:10.1111/j.1651-2227.2005.tb01786.x · Cited by 150 · see citing works
Role of a probiotic (Saccharomyces boulardii) in management and prevention of diarrhoea
Billoo, A. G. (2006) · World Journal of Gastroenterology · doi:10.3748/wjg.v12.i28.4557 · Cited by 136 · see citing works
Saccharomyces boulardii in acute childhood diarrhoea: a randomized, placebo‐controlled study
Villarruel, G., Rubio, D. M., López, F. G. B., Cintioni, J., Gurevech, R., Romero, G. G., & Vandenplas, Y. (2007) · Acta Paediatrica · doi:10.1111/j.1651-2227.2007.00191.x · Cited by 106 · see citing works
Htwe, K., Yee, K. S., Tin, M., & Vandenplas, Y. (2008) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.2008.78.214 · Cited by 93 · see citing works
META-ANALYSIS OF PROBIOTICS FOR THE PREVENTION AND TREATMENT OF ACUTE PEDIATRIC DIARRHEA
McFarland, L. V., Elmer, G. W., & Mcfarland, M. (2006) · Cited by 46 · see citing works
Eren, M., Dinleyici, E. Ç., & Vandenplas, Y. (2010) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.2010.09-0529 · Cited by 36 · see citing works
Luyer, B. L., Makhoul, G., & Duhamel, J.-F. (2010) · Archives de Pédiatrie · doi:10.1016/j.arcped.2010.02.004 · Cited by 20 · see citing works
Flagged first, then by citations
1 of the 12 references couldn’t be matched to a known paper.
Cited by
Sorted by citations
Probiotics for treating acute infectious diarrhoea
Allen, S. J., Martinez, E. G., Gregorio, G. V., & Dans, L. F. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003048.pub3 · Cited by 628 · see citing works
Arendrup, M. C., Boekhout, T., Akova, M., Meis, J. F. G. M., Cornely, O. A., & Lortholary, O. (2013) · Clinical Microbiology and Infection · doi:10.1111/1469-0691.12360 · Cited by 533 · see citing works
Modulatory Effects of Probiotics During Pathogenic Infections With Emphasis on Immune Regulation
Raheem, A., Liang, L., Zhang, G., & Cui, S. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.616713 · Cited by 315 · see citing works
Mokomane, M., Kasvosve, I., Melo, E. D., Pernica, J. M., & Goldfarb, D. M. (2018) · Therapeutic Advances in Infectious Disease · doi:10.1177/2049936117744429 · Cited by 262 · see citing works
Probiotics for treating acute infectious diarrhoea
Collinson, S., Deans, A., Padua-Zamora, A., Gregorio, G. V., Li, C., Dans, L. F., & Allen, S. J. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003048.pub4 · Cited by 153 · see citing works
Complete genome sequence and comparative genomics of the probiotic yeast Saccharomyces boulardii
Khatri, I., Tomar, R., Ganesan, K., Prasad, G. S., & Subramanian, S. (2017) · Scientific Reports · doi:10.1038/s41598-017-00414-2 · Cited by 130 · see citing works
AGA Technical Review on the Role of Probiotics in the Management of Gastrointestinal Disorders
Preidis, G. A., Weizman, A. V., Kashyap, P., & Morgan, R. L. (2020) · Gastroenterology · doi:10.1053/j.gastro.2020.05.060 · Cited by 135 · see citing works
Effectiveness and safety ofSaccharomyces boulardiifor acute infectious diarrhea
Dinleyici, E. Ç., Eren, M., Özen, M., Yargıç, Z. A., & Vandenplas, Y. (2012) · Expert Opinion on Biological Therapy · doi:10.1517/14712598.2012.664129 · Cited by 118 · see citing works
Efficacy and Safety of Saccharomyces boulardii for Acute Diarrhea
Feizizadeh, S., Salehi‐Abargouei, A., & Akbari, V. (2014) · PEDIATRICS · doi:10.1542/peds.2013-3950 · Cited by 95 · see citing works
Ansari, F., Samakkhah, S. A., Bahadori, A., Jafari, S. M., Ziaee, M., Khodayari, M. T., & Pourjafar, H. (2021) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2021.1949577 · Cited by 94 · see citing works
Safety of probiotics and synbiotics in children under 18 years of age
van den Nieuwboer, M., Brummer, R. J., Guarner, F., Morelli, L., Cabana, M., & Claassen, E. (2015) · Beneficial Microbes · doi:10.3920/bm2014.0157 · Cited by 83 · see citing works
Review article: the management of acute gastroenteritis in children
Pieścik‐Lech, M., Shamir, R., Guarino, A., & Szajewska, H. (2012) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.12163 · Cited by 69 · see citing works
Aggarwal, S., Upadhyay, A., Shah, D., Teotia, N., Agarwal, A., & Jaiswal, V. K. (2014) · Europe PMC (PubMed Central) · Cited by 56 · see citing works
Huang, R., Xing, H.-Y., Liu, H.-J., Chen, Z.-F., & Tang, B.-B. (2021) · Translational Pediatrics · doi:10.21037/tp-21-511 · Cited by 48 · see citing works
Saccharomyces boulardii CNCM I-745 in different clinical conditions
Dinleyici, E. Ç., Kara, A., Özen, M., & Vandenplas, Y. (2014) · Expert Opinion on Biological Therapy · doi:10.1517/14712598.2014.937419 · Cited by 49 · see citing works
Li, Z., Zhu, G., Li, C., Lai, H., Liu, X., & Zhang, L. (2021) · Nutrients · doi:10.3390/nu13124319 · Cited by 52 · see citing works
Common Organisms and Probiotics: Saccharomyces boulardii
McFarland, L. V. (2017) · Elsevier eBooks · doi:10.1016/b978-0-12-804024-9.00018-5 · Cited by 47 · see citing works
Szajewska, H., Kołodziej, M., & Zalewski, B. (2020) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.15659 · Cited by 47 · see citing works
Probiotics and Prebiotics in Infants and Children
Vandenplas, Y., Greef, E. D., Devreker, T., Veereman-Wauters, G., & Hauser, B. (2013) · Current Infectious Disease Reports · doi:10.1007/s11908-013-0334-4 · Cited by 38 · see citing works
Saccharomyces Boulardii in Helicobacter Pylori Eradication in Children: A Randomized Trial From Iran
Namkin, K., Zardast, M., & Basirinejad, F. (2016) · Iranian Journal of Pediatrics · doi:10.5812/ijp.3768 · Cited by 36 · see citing works
Mourey, F., Sureja, V., Kheni, D., Shah, P., Parikh, D., Upadhyay, U., Satia, M., Shah, D., Troise, C., & Decherf, A. (2020) · Pediatric Infectious Disease Journal · doi:10.1097/inf.0000000000002849 · Cited by 33 · see citing works
Hamedi, H., Misaghi, A., Modarressi, M. H., Salehı, T. Z., Khorasanizadeh, D., & Khalaj, V. (2013) · Europe PMC (PubMed Central) · Cited by 29 · see citing works
Hegar, B., Waspada, I. M. I., Gunardi, H., & Vandenplas, Y. (2014) · The Indian Journal of Pediatrics · doi:10.1007/s12098-014-1408-5 · Cited by 27 · see citing works
Role of probiotics in prevention of Candida infection in critically ill children
Kumar, S., & Singhi, S. C. (2012) · Mycoses · doi:10.1111/myc.12021 · Cited by 24 · see citing works
Săsăran, M. O., Mărginean, C. O., Adumitrăchioaiei, H., & Meliţ, L. E. (2023) · Nutrients · doi:10.3390/nu15030643 · Cited by 20 · see citing works
Specific Probiotics for the Treatment of Pediatric Acute Gastroenteritis in India
McFarland, L. V., Srinivasan, R., Setty, R., Ganapathy, S., Bavdekar, A., Mitra, M., Raju, B. B., & Mohan, N. (2021) · JPGN Reports · doi:10.1097/pg9.0000000000000079 · Cited by 17 · see citing works
Fu, H., Li, J., Xu, X., Xia, C., & Pan, Y. (2022) · Computational and Mathematical Methods in Medicine · doi:10.1155/2022/6234858 · Cited by 17 · see citing works
Global Emergency Medicine: A Review of the Literature From 2012
Jacquet, G. A., Foran, M. P., Bartels, S. A., Becker, T. K., Schroeder, E. D., Duber, H. C., Goldberg, E. M., Cockrell, H. C., Levine, A. C., & the Global Emergency Medicine Literature Review (GEMLR) Group (2013) · Academic Emergency Medicine · doi:10.1111/acem.12173 · Cited by 17 · see citing works
Indian Academy of Pediatrics Consensus Guidelines for Probiotic Use in Childhood Diarrhea
Yachha, S. K., Sarma, M. S., Mohan, N., Wadhwa, N., Vr, N. K., Srinivasan, R., Shah, D., Soans, S., Yewale, V. N., Basavaraja, G., et al. (2022) · Indian Pediatrics · doi:10.1007/s13312-022-2557-7 · Cited by 13 · see citing works
Padayachee, M., Visser, J., Viljoen, E., Musekiwa, A., & Blaauw, R. (2019) · South African Journal of Clinical Nutrition · doi:10.1080/16070658.2018.1449378 · Cited by 15 · see citing works
Sheele, J. M., Cartowski, J., Dart, A., Poddar, A., Gupta, S., Stashko, E., Ravi, B. S., Nelson, C., & Gupta, A. (2015) · Pathogens and Global Health · doi:10.1179/2047773215y.0000000028 · Cited by 12 · see citing works
Anti-Hypercholesterolemic Effect of Saccharomyces boulardii in the Hamster
Girard, P., Pansart, Y., & Verleye, M. (2014) · Pharmacology · doi:10.1159/000365009 · Cited by 10 · see citing works
Saa, C., Bunout, D., & Hirsch, S. (2019) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0000000000001322 · Cited by 10 · see citing works
Wang, G., & Feng, D. (2019) · Experimental and Therapeutic Medicine · doi:10.3892/etm.2019.7836 · Cited by 9 · see citing works
Tolulope, P. A., & Julius, K. O. (2020) · AFRICAN JOURNAL OF BIOTECHNOLOGY · doi:10.5897/ajb2019.16814 · Cited by 7 · see citing works
Ragavan, P. S. K., Kaur, A., Kumar, M., Singhal, V., Patel, A., Khunt, A., Shah, R., Wazeer, S., Rathod, R., Mane, A., et al. (2020) · New Microbes and New Infections · doi:10.1016/j.nmni.2020.100766 · Cited by 5 · see citing works
Ahmadi, M., Mohtasham, N., Shamsizadeh, A., Javaherizadeh, H., Cheraghian, B., & Alizadeh, M. (2022) · Immunopathologia Persa · doi:10.34172/ipp.2022.31397 · Cited by 2 · see citing works
Addow, A. H., Jayte, M., Oburu, G. O., Odoch, S., Kaharuza, J., Alkali, B., Abshir, Y. A. H., Ali, H. O., & Elfakey, W. (2025) · Scientific Reports · doi:10.1038/s41598-025-31626-6 · Cited by 1 · see citing works
ESCMID/ECMM Joint Clinical Guideline for the Diagnosis and Management of Rare Invasive Yeast
Arendrup, M. C., Boekhout, T., Akova, M., & Cornely, O. A. (2013) · Cited by 1 · see citing works
Madhumathi, I., Ramesh, V., Rathakrishnan, B., Abirami, B., Gunasekaran, K., Kumar, T. S., Jeyasankar, P., Raja, G., Selvam, K., Rajendran, S., et al. (2026) · Gut microbes reports · doi:10.1080/29933935.2026.2668863
“9,36,37 Globally, regulatory inconsistency prevails.”
Lactobacillus GG for Treatment of Acute Childhood Diarrhoea
Jain, S. (2019) · Asian Journal of Medical Research · doi:10.21276/ajmr.2019.8.2.pe2
Guía colombiana para el uso de probióticos en patologías pediátricas
Monroy, F. A. M., Ángel, A. F. G., Carrillo, M. M. H., Camacho, J. F. G., López, J. P. R., Calderón-Guerrero, O. G., Becerra, M. E., Sarmiento, G. E. S., Hernández, H. H. L., Giraldo, F. J. S., et al. (2024) · Acta gastroenteorológica latinoamericana/Acta gastroenterológica latinoamericana · doi:10.52787/agl.v54i2.395
Hegar, S. B. (2015) · VUBIR (Vrije Universiteit Brussel)
- Authors
- Riaz, M., Alam, S., Malik, A., & Ali, S. M.
- Affiliations
- Aligarh Muslim University (IN)
- Institute of Liver and Biliary Sciences (IN)
- Corresponding author
- Alam, Seema
- ORCID
- Alam, Seema
- Venue
- The Indian Journal of Pediatrics
- Published
- 2011-10-14
- Volume
- 79
- Issue
- 4
- Pages
- 478-482
- ISSN
- 0019-5456 (ISSN-L)
- 0973-7693
- OpenAlex
- W2052793123
- Cited by
- 43
- References
- 12
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 1 · 2023: 1 · 2022: 3 · 2021: 5 · 2020: 6 · 2019: 2 · 2018: 2 · 2017: 3 · 2016: 1 · 2015: 3 · 2014: 5 · 2013: 5 · 2012: 3
- FWCI
- 6.07
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- The Indian Journal of Pediatrics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Infectious Diseases › Viral gastroenteritis research and epidemiology
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- Saccharomyces boulardii, acute childhood diarrhea, probiotics, diarrhea duration, children under five, treatment efficacy and safety
- MeSH terms
- Acute Disease, Child, Child, Preschool, Developing Countries, Diarrhea, Double-Blind Method, Drug Administration Schedule, Female, Humans, India, Infant, Male, Saccharomyces, Treatment Outcome, Probiotics
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