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Bacillus clausii therapy to reduce side-effects of anti-Helicobacter pylori treatment: randomized, double-blind, placebo controlled trial
Open accessAbstract
Summary: Background : Helicobacter pylori eradication fails in about 10% of patients, particularly because of the occurrence of resistance to antibiotics and side‐effects. During anti‐H. pylori therapy, probiotics have been successfully used to reduce the incidence of side‐effects. Aim : To evaluate the effect of Bacillus clausii, a probiotic, on incidence (primary variable) and severity of antibiotic‐associated side‐effects during anti‐H. pylori therapy. Methods : One hundred and twenty H. pylori‐positive patients were randomly screened to receive: (i) a standard 7 days triple therapy with rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and amoxicillin 1 g b.d. and B. clausii t.d.s. (each preparation containing 2 × 10 9 spores) for 14 days starting from the first day of treatment. (ii) The same 7 days triple therapy and placebo t.d.s. for 14 days starting from the first day of treatment. Side‐effects were assessed using a validated questionnaire and were recorded for 4 weeks from the start of therapy. Results : The incidences of nausea, diarrhoea and epigastric pain in patients treated with B. clausii were significantly lower than in placebo group, in both PP and ITT analysis. Equally, intensity of nausea and diarrhoea in patients treated with B. clausii was significantly lower than in placebo group. There were no differences in adherence to treatment and H. pylori eradication rates between groups. Conclusion : In symptom‐free, H. pylori‐positive subjects B. clausii bacteriotherapy reduces the incidence of the most common side‐effects related to anti‐H. pylori antibiotic therapy compared with placebo.
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“However, the results for two of the probiotic treatments were mixed, with a significant benefit of the specific probiotic treatment seen after 1 week, but not 2 weeks, in one study,49 and significantly fewer days with diarrhoea and shorter mean duration of diarrhoea episodes, but no significant difference in frequency of diarrhoea episodes, in the probiotic group compared with the placebo group in”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [49]
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“All four studies reported a significant benefit of specific probiotic treatments compared with placebo.46–49”
From Systematic review: probiotics in the management of lower gastrointestinal symptoms in clinical practice - an evidence-based international guide (2013) · cites this paper as [49]
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Malfertheiner, P., Mégraud, F., O'Morain, C. A., Hungin, A. P. S., Jones, R. H., Axon, A. T. R., Graham, D. Y., Tytgat, G. N. J., & The European Helicobacter Pylori Study Group (EHPSG) (2002) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.2002.01169.x · Cited by 1,238
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Meta‐analysis: the effect of probiotic administration on antibiotic‐associated diarrhoea
Cremonini, F., Caro, S. D., Nista, E. C., Bartolozzi, F., Capelli, G., Gasbarrini, A., & Gasbarrini, A. (2002) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.2002.01318.x · Cited by 386
Self-citationCremonini, F., Caro, S., Covino, M., Armuzzi, A., Gabrielli, M., Santarelli, L., Nista, E. C., Cammarota, G., Gasbarrini, G., & Gasbarrini, A. (2002) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2002.07063.x · Cited by 341
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Self-citationIsolauri, E. (2001) · American Journal of Clinical Nutrition · doi:10.1093/ajcn/73.6.1142s · Cited by 290
Laine, L., Hunt, R. H., El-Zimaity, H. M. T., Nguyen, B., Osato, M. S., & Spénard, J. (2003) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2003.t01-1-07288.x · Cited by 242
High eradication rates of Helicobacter pylori with a new sequential treatment
Zullo, A., Vaira, D., Vakil, N. B., Hassan, C., Gatta, L., Ricci, C., Francesco, V. D., Menegatti, M., Tampieri, A., Perna, F., et al. (2003) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.2003.01461.x · Cited by 221
Bacillus clausii Probiotic Strains
Urdaci, M. C., Bressollier, P., & Pinchuk, I. (2004) · Journal of Clinical Gastroenterology · doi:10.1097/01.mcg.0000128925.06662.69 · Cited by 182
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Management of Helicobacter pylori infection—the Maastricht V/Florence Consensus Report
Malfertheiner, P., Mégraud, F., O'Morain, C. A., Gisbert, J. P., Kuipers, E. J., Axon, A. T. R., Bazzoli, F., Gasbarrini, A., Atherton, J. C., Graham, D. Y., et al. (2016) · Gut · doi:10.1136/gutjnl-2016-312288 · Cited by 3,023
Self-citationMcFarland, L. V. (2006) · The American Journal of Gastroenterology · doi:10.1111/j.1572-0241.2006.00465.x · Cited by 872
Cutting, S. M. (2010) · Food Microbiology · doi:10.1016/j.fm.2010.03.007 · Cited by 827
Functional cultures and health benefits
Shah, N. P. (2007) · International Dairy Journal · doi:10.1016/j.idairyj.2007.01.014 · Cited by 793
Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children
Goldenberg, J. Z., Ma, S. S., Saxton, J. D., Martzen, M. R., Vandvik, P. O., Thorlund, K., Guyatt, G. H., & Johnston, B. C. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006095.pub3 · Cited by 741
Metadata
- Authors
- Nista, E. C., Candelli, M., Cremonini, F., Cazzato, I. A., Zocco, M. A., Franceschi, F., Cammarota, G., Gasbarrini, G., & Gasbarrini, A.
- Affiliations
- Università Cattolica del Sacro Cuore (IT)
- Venue
- Alimentary Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 2004-11
- Volume
- 20
- Issue
- 10
- Pages
- 1181-1188
- ISSN
- 0269-2813 (ISSN-L)
- 1365-2036
- OpenAlex
- W2120773585
- Cited by
- 212
- References
- 27
- Citations by year
- 2026: 4 · 2025: 2 · 2024: 12 · 2023: 15 · 2022: 29 · 2021: 8 · 2020: 6 · 2019: 7 · 2018: 2 · 2017: 9 · 2016: 11 · 2015: 9 · 2014: 8 · 2013: 16 · 2012: 11
- FWCI
- 11.37
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Alimentary Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Helicobacter pylori-related gastroenterology studies
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- Bacillus clausii, probiotics, Helicobacter pylori eradication, antibiotic adverse effects, triple therapy, clarithromycin, amoxicillin, rabeprazole, nausea, diarrhea, epigastric pain, Helicobacter pylori infection
- MeSH terms
- Adolescent, Adult, Aged, Amoxicillin, Anti-Ulcer Agents, Bacillus, Benzimidazoles, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Omeprazole, Prospective Studies, Helicobacter pylori, Helicobacter Infections, Clarithromycin, Probiotics, 2-Pyridinylmethylsulfinylbenzimidazoles, Rabeprazole
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