title: Efficacy and safety of Saccharomyces boulardii in prevention of antibiotic-associated diarrhoea due to Helicobacterpylori eradication.
abstract: OBJECTIVE
  Antibiotic-associated diarrhoea may develop during or following Helicobacter pylori eradication. We aimed to evaluate the efficacy and safety of Saccharomyces boulardii in preventing antibiotic-associated diarrhoea in patients receiving antibiotics for H. pylori eradication.
  
  
  METHODS
  In a multicentre prospective clinical trial, patients with peptic ulcer disease or non-ulcer dyspepsia were enrolled to receive clarithromycin, amoxicillin and omeprazole for H. pylori eradication for 14 days. These patients were then randomized to receive either S. boulardii 500 mg twice daily (treatment group) or no treatment (control group). The primary outcome measure was the development of diarrhoea during (treatment period) or within 4 weeks after treatment (follow-up period).
  
  
  RESULTS
  Of the 389 patients that were enrolled, 376 completed the study. Within the treatment period, diarrhoea developed in 5.9% of patients in the treatment group and in 11.5% of patients in the control group (P = 0.049); and in the follow-up period, diarrhoea developed in 1.0% of patients in the treatment group and in 3.8% of patients in the control group (P = 0.09). Overall diarrhoea rates throughout the whole study period were 6.9% in the treatment group and 15.6% in the control group (P = 0.007). No significant difference was observed between the treatment and control groups in terms of adverse events.
  
  
  CONCLUSIONS
  S. boulardii is an effective and safe treatment for prevention of antibiotic-associated diarrhoea when given concomitantly to patients receiving H. pylori eradication.
authors.affiliation: Department of Gastroenterology, Marmara University, School of Medicine, Istanbul, Turkey.
authors.forename: Deniz Güney
authors.initials: DG
authors.lastname: Duman
authors.forename: Serhat
authors.initials: S
authors.lastname: Bor
authors.forename: Omer
authors.initials: O
authors.lastname: Ozütemiz
authors.forename: Tülin
authors.initials: T
authors.lastname: Sahin
authors.forename: Dilek
authors.initials: D
authors.lastname: Oğuz
authors.forename: Fahri
authors.initials: F
authors.lastname: Iştan
authors.forename: Tümer
authors.initials: T
authors.lastname: Vural
authors.forename: Macit
authors.initials: M
authors.lastname: Sandkci
authors.forename: Fatih
authors.initials: F
authors.lastname: Işksal
authors.forename: Ilkay
authors.initials: I
authors.lastname: Simşek
authors.forename: Müjde
authors.initials: M
authors.lastname: Soytürk
authors.forename: Serap
authors.initials: S
authors.lastname: Arslan
authors.forename: Bülent
authors.initials: B
authors.lastname: Sivri
authors.forename: Irfan
authors.initials: I
authors.lastname: Soykan
authors.forename: Ayşegül
authors.initials: A
authors.lastname: Temizkan
authors.forename: Fatih
authors.initials: F
authors.lastname: Beşşk
authors.forename: Sabahattin
authors.initials: S
authors.lastname: Kaymakoğlu
authors.forename: Cem
authors.initials: C
authors.lastname: Kalayc
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced / Q000517:prevention & control*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D012440:Saccharomyces; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents