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Background:
Systematic Review

Effectiveness of Bacillus clausii (O/C, N/R, SIN, T) in the Prevention of Antibiotic-Associated Diarrhea and Gastrointestinal Symptoms: A Systematic Review

by
Ana Teresa Abreu
1,*,
Rodrigo Vázquez Frías
2,
Christian Boggio Marzet
3,
Juan Pablo Stefanolo
4,
Alejandro Concha Mejía
5,
Luis Bustos Fernández
6,
Oscar Laudanno
7,
Dimas Rosa
8,
Maria Claudia Cruz Serrano
9,
Karen Cárdenas
10 and
Julio Zuluaga
10
1
Hospital Angeles del Pedregal, Mexico City 10700, Mexico
2
Hospital Infantil de México Federico Gómez, Mexico City 06720, Mexico
3
Grupo de Trabajo en Gastroenterología y Nutrición Pediátrica, Hospital Gral. de Agudos “Dr. I. Pirovano”, Buenos Aires C1428, Argentina
4
Neurogastroenterology Laboratory, Favaloro Foundation–University Hospital, Buenos Aires C1095, Argentina
5
Clínica del Country, Clínica la Colina, Hospital Universitario Nacional de Colombia, Universidad Nacional de Colombia, Bogotá 111321, Colombia
6
Centro Médico Dr. Bustos Fernández, Buenos Aires C1428, Argentina
7
Instituto de Investigaciones Médicas Alfredo Lanari, Universidad de Buenos Aires, Buenos Aires C1427, Argentina
8
Grupo de Investigación del Caribe y Centroamérica para la Microbiota, Probióticos y Prebióticos GICCAMPP, Santa Marta 470001, Colombia
9
Opella, a Sanofi Company, Bogotá 110121, Colombia
10
Odds Epidemiology, Bogotá 111321, Colombia
*
Author to whom correspondence should be addressed.
Antibiotics 2025, 14(5), 439; https://doi.org/10.3390/antibiotics14050439
Submission received: 28 February 2025 / Revised: 11 April 2025 / Accepted: 22 April 2025 / Published: 27 April 2025

Abstract

Background: Dysbiosis and antibiotic-associated diarrhea (AAD) are significant concerns in clinical settings. Probiotics, such as Bacillus clausii (O/C, N/R, SIN, T), a spore-forming bacterium resistant to gastrointestinal conditions and most commonly used antibiotics, emerge as a promising approach. We aim to assess the role of B. clausii in preventing AAD in children and adults during antibiotic therapy. Materials and methods: A systematic literature search was conducted across multiple databases, including MEDLINE, EMBASE, Cochrane Library, LILACS, and SciELO, up to May 2024. Studies were included if they involved B. clausii (O/C, N/R, SIN, T) administration during antibiotic treatment and reported AAD-related outcomes. Results: A total of four studies were included in the review. The studies comprised two randomized controlled trials (RCTs), one meta-analysis of RCTs, and one expert consensus. The primary outcome was the effectiveness of B. clausii (O/C, N/R, SIN, T) in reducing the incidence of diarrhea. Results showed a significant reduction in the risk of AAD and gastrointestinal symptoms in patients receiving it at a dosage of 4 × 109 CFU/day for children and 6 × 109 CFU/day for adolescents and adults for up to 14 days. Conclusions: B. clausii (O/C, N/R, SIN, T) appears to be an effective probiotic for preventing AAD in adults and children. It significantly improves gastrointestinal symptoms associated with antibiotic treatment, including diarrhea, nausea, and epigastric pain. Future studies are recommended to further elucidate its effectiveness in diverse populations, especially in low- and middle-income countries.
Keywords: Bacillus clausii; antibiotic-associated diarrhea; probiotics; dysbiosis; systematic review Bacillus clausii; antibiotic-associated diarrhea; probiotics; dysbiosis; systematic review

Share and Cite

MDPI and ACS Style

Abreu, A.T.; Vázquez Frías, R.; Boggio Marzet, C.; Stefanolo, J.P.; Concha Mejía, A.; Bustos Fernández, L.; Laudanno, O.; Rosa, D.; Cruz Serrano, M.C.; Cárdenas, K.; et al. Effectiveness of Bacillus clausii (O/C, N/R, SIN, T) in the Prevention of Antibiotic-Associated Diarrhea and Gastrointestinal Symptoms: A Systematic Review. Antibiotics 2025, 14, 439. https://doi.org/10.3390/antibiotics14050439

AMA Style

Abreu AT, Vázquez Frías R, Boggio Marzet C, Stefanolo JP, Concha Mejía A, Bustos Fernández L, Laudanno O, Rosa D, Cruz Serrano MC, Cárdenas K, et al. Effectiveness of Bacillus clausii (O/C, N/R, SIN, T) in the Prevention of Antibiotic-Associated Diarrhea and Gastrointestinal Symptoms: A Systematic Review. Antibiotics. 2025; 14(5):439. https://doi.org/10.3390/antibiotics14050439

Chicago/Turabian Style

Abreu, Ana Teresa, Rodrigo Vázquez Frías, Christian Boggio Marzet, Juan Pablo Stefanolo, Alejandro Concha Mejía, Luis Bustos Fernández, Oscar Laudanno, Dimas Rosa, Maria Claudia Cruz Serrano, Karen Cárdenas, and et al. 2025. "Effectiveness of Bacillus clausii (O/C, N/R, SIN, T) in the Prevention of Antibiotic-Associated Diarrhea and Gastrointestinal Symptoms: A Systematic Review" Antibiotics 14, no. 5: 439. https://doi.org/10.3390/antibiotics14050439

APA Style

Abreu, A. T., Vázquez Frías, R., Boggio Marzet, C., Stefanolo, J. P., Concha Mejía, A., Bustos Fernández, L., Laudanno, O., Rosa, D., Cruz Serrano, M. C., Cárdenas, K., & Zuluaga, J. (2025). Effectiveness of Bacillus clausii (O/C, N/R, SIN, T) in the Prevention of Antibiotic-Associated Diarrhea and Gastrointestinal Symptoms: A Systematic Review. Antibiotics, 14(5), 439. https://doi.org/10.3390/antibiotics14050439

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