J Trop Pediatr. 2004 Aug;50(4):234-6.

The probiotic effect of Saccharomyces boulardii in a pediatric age group. Erdeve O, Tiras U, Dallar Y. Ankara Education and Research Hospital, Ankara, Turkey. omererdeve@yahoo.com The aim of this study was to determine the efficacy of S. boulardii in diarrhea associated with commonly used antibiotics such as sulbactam-ampicillin (SAM) and azithromycin (AZT). Four hundred and sixty-six patients were assigned to four different groups as follows: group 1:117 patients receiving SAM alone; group 2:117 patients receiving SAM and S. boulardii, group 3:105 patients receiving AZT alone; group 4:127 patients receiving AZT and S. boulardii. Antibiotic-associated diarrhea was seen in 42 of the 222 patients (18.9 per cent) receiving an antibiotic without the probiotic, and in 14 of the 244 patients (5.7 per cent) who received both the probiotic and the antibiotic (p < 0.05). In the group receiving SAM where S. boulardii use was found to be significant, the use of S. boulardii decreased the diarrhea rate from 32.3 to 11.4 per cent in the 1-5 years age group (p < 0.05). This is a pioneering study investigating combined antibiotic and probiotic use in pediatric diarrhea patients. Publication Types:

Clinical Trial

PMID: 15357564 [PubMed - indexed for MEDLINE]

 

Acta Paediatr. 2005 Jan;94(1):44-7.

Effects of Saccharomyces boulardii in children with acute diarrhoea. Kurugol Z, Koturoglu G. Department of Paediatrics, Faculty of Medicine, Ege University, Izmir, Turkey. kurugol@med.ege.edu.tr AIM: Certain probiotic agents, e.g. Lactobacillus GG, have shown efficacy in clinical trials for the treatment of acute childhood diarrhoea, but few studies have examined the effect of Saccharomyces boulardii. We evaluated the effect of S. boulardii in children with acute diarrhoea. METHODS: Two hundred children were randomized to receive S. boulardii in a granulated form in a daily dose of 250 mg (S. boulardii group) or placebo (placebo group) for 5 d. Clinical and demographic characteristics on admission were similar between the study groups. RESULTS: The medians of the average stool frequency after the second day of the treatment were significantly lower in the S. boulardii group than in the placebo group (p = 0.003). The duration of diarrhoea significantly reduced in the S. boulardii group compared with the placebo group (4.7 vs 5.5 d, p = 0.03). The effect of S. boulardii on watery diarrhoea became apparent after the second day of the treatment. The duration of hospital stay was shorter in the S. boulardii group than in the placebo group (2.9 vs 3.9 d, p < 0.001). Four children from the placebo group versus only one child from the S. boulardii group had persisting diarrhoea. CONCLUSION: The placebo-controlled study suggested that S. boulardii significantly reduced the duration of acute diarrhoea and the duration of hospital stay. S. boulardii seems to be a promising agent for the amelioration of the course of acute diarrhoea in children when used therapeutically. Publication Types:

Clinical Trial
Randomized Controlled Trial

PMID: 15858959 [PubMed - indexed for MEDLINE]

 

 

Aliment Pharmacol Ther. 2005 Mar 1;21(5):583-90.

Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea in children: a randomized double-blind placebo-controlled trial. Kotowska M, Albrecht P, Szajewska H. Department of Pediatric Gastroenterology and Nutrition, The Medical University of Warsaw, Warsaw, Poland. BACKGROUND: Co-treatment with Saccharomyces boulardii appears to lower the risk of antibiotic-associated diarrhoea in adults receiving broad-spectrum antibiotics. AIM: To determine whether S. boulardii prevents antibiotic-associated diarrhoea in children. METHODS: A total of 269 children (aged 6 months to 14 years) with otitis media and/or respiratory tract infections were enrolled in a double-blind, randomized placebo-controlled trial in which they received standard antibiotic treatment plus 250 mg of S. boulardii (experimental group, n = 132) or a placebo (control group, n = 137) orally twice daily for the duration of antibiotic treatment. Analyses were based on allocated treatment and included data from 246 children. RESULTS: Patients receiving S. boulardii had a lower prevalence of diarrhoea (> or =3 loose or watery stools/day for > or =48 h occurring during or up to 2 weeks after the antibiotic therapy) than those receiving placebo [nine of 119 (8%) vs. 29 of 127 (23%), relative risk: 0.3, 95% confidence interval: 0.2-0.7]. S. boulardii also reduced the risk of antibiotic-associated diarrhoea (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared with placebo [four of 119 (3.4%) vs. 22 of 127 (17.3%), relative risk: 0.2; 95% confidence interval: 0.07-0.5]. No adverse events were observed. CONCLUSION: This is the first randomized-controlled trial evidence that S. boulardii effectively reduces the risk of antibiotic-associated diarrhoea in children. Publication Types:

Clinical Trial
Randomized Controlled Trial

PMID: 15740542 [PubMed - indexed for MEDLINE]

Aliment Pharmacol Ther. 2005 Sep 1;22(5):365-72.

 

 Meta-analysis: non-pathogenic yeast Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea. Szajewska H, Mrukowicz J. Department of Pediatric Gastroenterology and Nutrition, The Medical University of Warsaw, Warsaw, Poland. Background : Antibiotic-associated diarrhoea occurs in up to 30% of patients who receive antibiotics but can be prevented with probiotics. Aim : To systematically evaluate the effectiveness of Saccharomyces boulardii in preventing antibiotic-associated diarrhoea in children and adults. Methods : Using medical subject headings and free-language terms, the following electronic databases were searched for studies relevant to antibiotic-associated diarrhoea and S. boulardii: MEDLINE, EMBASE, CINAHL and The Cochrane Library. Additional sources were obtained from references in reviewed articles. Only randomized-controlled trials were considered for study inclusion. Results : Of 16 potentially relevant clinical trials identified, five randomized-controlled trials (1076 participants) met the inclusion criteria for this systematic review. Treatment with S. boulardii compared with placebo reduced the risk of antibiotic-associated diarrhoea from 17.2% to 6.7% (RR: 0.43; 95% CI: 0.23-0.78; random effect model). The number needed to treat to prevent one case of antibiotic-associated diarrhoea was 10 (95% CI: 7-16). No side-effects were reported. Conclusions : A meta-analysis of data from five randomized-controlled trials showed that S. boulardii is moderately effective in preventing antibiotic-associated diarrhoea in children and adults treated with antibiotics for any reason (mainly respiratory tract infections). For every 10 patients receiving daily S. boulardii with antibiotics, one fewer will develop antibiotic-associated diarrhoea. PMID: 16128673 [PubMed - in process]

 

 

Am J Gastroenterol. 1995 Mar;90(3):439-48.

Prevention of beta-lactam-associated diarrhea by Saccharomyces boulardii compared with placebo. McFarland LV, Surawicz CM, Greenberg RN, Elmer GW, Moyer KA, Melcher SA, Bowen KE, Cox JL. Department of Medicinal Chemistry, University of Washington, Seattle. OBJECTIVES: To determine the safety and efficacy of a new preventive agent for antibiotic-associated diarrhea (AAD) in patients receiving at least one beta-lactam antibiotic. METHODS: A double-blinded, placebo-controlled, parallel group study was performed in a high-risk group of hospitalized patients receiving a new prescription for a beta-lactam antibiotic and having no acute diarrhea on enrollment. Lyophilized Saccharomyces boulardii or placebo (1 g/day) was given within 72 h of the start of the antibiotic(s) and continued until 3 days after the antibiotic was discontinued, after which the patients were followed for 7 wk. RESULTS: Of the 193 eligible patients, significantly fewer, 7/97 (7.2%), patients receiving S. boulardii developed AAD compared with 14/96 (14.6%) on placebo (p = 0.02). The efficacy of S. boulardii for the prevention of AAD was 51%. Using a multivariate model to adjust for two independent risk factors for AAD (age and days of cephalosporin use), the adjusted relative risk was significantly protective for S. boulardii (RR = 0.29, 95% CI = 0.08, 0.98). CONCLUSION: The prophylactic use of S. boulardii given with a beta-lactam antibiotic resulted in a significant reduction of AAD with no serious adverse reactions. Publication Types:

Clinical Trial
Multicenter Study
Randomized Controlled Trial

PMID: 7872284 [PubMed - indexed for MEDLINE]