Saccharomyces boulardii CNCM I-745 plus sequential therapy for Helicobacter pylori infections: a randomized, open-label trial
- 20 Downloads
To determine the effect of Saccharomyces boulardii CNCM I-745 (S. boulardii) plus sequential therapy on Helicobacter pylori (H. pylori) eradication rate.
This open-label prospective study randomized (1:1) patients with confirmed H. pylori infection to standard sequential therapy of twice-daily (bid) omeprazole 20 mg plus amoxicillin 1 g for 5 days, followed by bid omeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg for the next 5 days (control group), or sequential therapy plus bid S. boulardii 250 mg (experimental group). Adverse events (AEs) were recorded throughout the study, and the H. pylori eradication rate was determined 4 weeks after treatment.
The study was conducted from May 2013 to May 2016 and included 199 patients (51.3% male; mean age 44.6 ± 13.6 years). The H. pylori eradication rate was higher in the experimental group than the control group (86.0% vs. 74.7%; P = 0.02). Compared with the control group, patients in the experimental group experienced a significantly lower overall incidence of AEs (17.0% vs. 55.7%; p < 0.001) and the incidence of antibiotic-associated diarrhea (2.0% vs. 46.4%; P = 0.02). The experimental group showed improved treatment compliance over the 10-day study period compared with the control group (95.0% vs. 91.2%, P < 0.001).
Addition of S. boulardii to sequential therapy improved H. pylori eradication rate and reduced the incidence of treatment-associated AEs in Moroccan patients with H. pylori infection.
KeywordsAntibiotic-induced diarrhea Helicobacter pylori H. pylori eradication rate Saccharomyces boulardii Sequential treatment Treatment compliance
The authors thank Nishad Parkar, PhD, of Springer Healthcare Communications for technical and English editing of the manuscript prior to submission. This medical writing assistance was funded by Biocodex.
Hassan Seddik was responsible for study concept and planning and supervised the statistical analysis and redaction of the manuscript. Hanae Boutallaka was involved in performing the statistical analysis and writing the manuscript, with input from all authors. Fouad Nejjari, Reda Berraida, Khaoula Loubaris, Ilham Elkoti, Sanaa Berrag and Sara Sentissi were involved in patient enrollment and data collection and were involved in the preparation of the manuscript. Ahmed Benkirane was involved in conducting and supervising the study.
Support was provided by Biocodex, France.
Compliance with ethical standards
Informed consent statement
All patients included in the study provided written informed consent before the study commenced.
Conflict of interest
The authors have no conflicts of interest to declare.
CONSORT 2010 statement
The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
- 1.Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC (2017) Global prevalence of Helicobacter pylori infection: systematic review and meta-analysis. Gastroenterology 153(2):420–429. https://doi.org/10.1053/j.gastro.2017.04.022 CrossRefGoogle Scholar
- 2.Sjomina O, Heluwaert F, Moussata D, Leja M (2017) Helicobacter pylori infection and nonmalignant diseases. Helicobacter 22(Suppl 1). https://doi.org/10.1111/hel.12408
- 5.Benajah DA, Lahbabi M, Alaoui S, El Rhazi K, El Abkari M, Nejjari C, Amarti A, Bennani B, Mahmoud M, Ibrahimi SA (2013) Prevalence of Helicobacter pylori and its recurrence after successful eradication in a developing nation (Morocco). Clin Res Hepatol Gastroenterol 37(5):519–526. https://doi.org/10.1016/j.clinre.2013.02.003 CrossRefGoogle Scholar
- 9.World Health Organization Global priority list of antibiotic-resistant bacteria to guide research, discovery and development of new antibiotics. 27 February 2017 [cited 04 April 2018]. In: WHO Publications [Internet]. World Health Organization, Geneva. Available from: http://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf?ua=1
- 10.Malfertheiner P, Megraud F, O’Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM (2017) Management of Helicobacter pylori infection-the Maastricht V/Florence consensus report. Gut 66(1):6–30. https://doi.org/10.1136/gutjnl-2016-312288 CrossRefGoogle Scholar
- 12.Munteanu D, Etzion O, Ben-Yakov G, Halperin D, Eidelman L, Schwartz D, Novack V, Abufreha N, Krugliak P, Rozenthal A, Gaspar N, Moshkalo A, Dizingof V, Fich A (2017) Efficacy and safety of sequential versus quadruple therapy as second-line treatment for Helicobacter pylori infection-a randomized controlled trial. PLoS One 12(9):e0183302. https://doi.org/10.1371/journal.pone.0183302 CrossRefGoogle Scholar
- 13.Tong J, Ran Z, Shen J, Zhang C, Xiao S (2007) Meta-analysis: the effect of supplementation with probiotics on eradication rates and adverse events during Helicobacter pylori eradication therapy. Aliment Pharmacol Ther 25(2):155–168. https://doi.org/10.1111/j.1365-2036.2006.03179.x CrossRefGoogle Scholar
- 17.Szajewska H, Horvath A, Piwowarczyk A (2010) Meta-analysis: the effects of Saccharomyces boulardii supplementation on Helicobacter pylori eradication rates and side effects during treatment. Aliment Pharmacol Ther 32(9):1069–1079. https://doi.org/10.1111/j.1365-2036.2010.04457.x CrossRefGoogle Scholar
- 18.Seddik H, Ahid S, El Adioui T, El Hamdi FZ, Hassar M, Abouqal R, Cherrah Y, Benkirane A (2013) Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a prospective randomized study. Eur J Clin Pharmacol 69(9):1709–1715. https://doi.org/10.1007/s00228-013-1524-6 CrossRefGoogle Scholar
- 21.Cindoruk M, Erkan G, Karakan T, Dursun A, Unal S (2007) Efficacy and safety of Saccharomyces boulardii in the 14-day triple anti-Helicobacter pylori therapy: a prospective randomized placebo-controlled double-blind study. Helicobacter 12(4):309–316. https://doi.org/10.1111/j.1523-5378.2007.00516.x CrossRefGoogle Scholar
- 22.IBM Corp. Released (2011) IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM CorpGoogle Scholar
- 23.Zojaji H, Ghobakhlou M, Rajabalinia H, Ataei E, Jahani Sherafat S, Moghimi- Dehkordi B, Bahreiny R (2013) The efficacy and safety of adding the probiotic Saccharomyces boulardii to standard triple therapy for eradication of H. pylori: a randomized controlled trial. Gastroenterol Hepatol Bed Bench 6(Suppl 1):S99–S104Google Scholar
- 28.Bouihat N, Burucoa C, Benkirane A, Seddik H, Sentissi S, Al Bouzidi A, Elouennas M, Benouda A (2017) Helicobacter pylori primary antibiotic resistance in 2015 in Morocco: a phenotypic and genotypic prospective and multicenter study. Microb Drug Resist 23(6):727–732. https://doi.org/10.1089/mdr.2016.0264 CrossRefGoogle Scholar
- 29.Zullo A, De Francesco V, Bellesia A, Vassallo R, D’Angelo A, Scaccianoce G, Sacco R, Bresci G, Eramo A, Tanzilli A, Ridola L, Alvaro D, Londoni C, Brambilla G, Manta R, Di Ciaula A, Portincasa P (2017) Bismuth-based quadruple therapy following H. pylori eradication failures: a multicenter study in clinical practice. J Gastrointestin Liver Dis 26(3):225–229Google Scholar
- 30.Gómez Rodríguez BJ, Castro Laria L, Argüelles Arias F, Castro Márquez C, Caunedo Álvarez Á, Romero Gómez M (2017) A real life study of Helicobacter pylori eradication with bismuth quadruple therapy in naive and previously treated patients. Rev Esp Enferm Dig 109(8):552–558. https://doi.org/10.17235/reed.2017.4809/2016 Google Scholar
- 34.Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS (2016) Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet 388(10058):2355–2365. https://doi.org/10.1016/s0140-6736(16)31409-x CrossRefGoogle Scholar
- 35.Bin Z, Ya-Zheng X, Zhao-Hui D, Bo C, Li-Rong J, Vandenplas Y (2015) The efficacy of Saccharomyces boulardii CNCM I-745 in addition to standard Helicobacter pylori eradication treatment in children. Pediatr Gastroenterol Hepatol Nutr 18(1):17–22. https://doi.org/10.5223/pghn.2015.18.1.17 CrossRefGoogle Scholar
- 36.Zhao HM, Ou-Yang HJ, Duan BP, Xu B, Chen ZY, Tang J, You JY (2014) Clinical effect of triple therapy combined with Saccharomyces boulardii in the treatment of Helicobacter pylori infection in children. Zhongguo Dang Dai Er Ke Za Zhi 16(3):230–233Google Scholar