DiarSafe Clinical Trials

1. Saccharomyces boulardii and infection due to Giardia lamblia

Besirbellioglu, Bulent1; Ulcay, Asim1; Can, Mehmet2; Erdem, Hakan1; Tanyuksel, Mehmet3; Avci, Ismail Yasar1; Araz, Engin3; Pahsa, Alaaddin1

Source: Scandinavian Journal of Infectious Diseases, Volume 38, Numbers 6-7, -7/July 2006, pp. 479-481(3)

Abstract:

Therapy with metronidazole is the recommended option in giardiasis. However, some clinical trial reports suggest the appearance of drug resistance to explain therapeutic failure. Several investigations have been carried out on the effect of probiotic microorganisms for preventing or treating gastrointestinal diseases, but little is known about their efficacy against protozoal infections. The principal objective of our study was to evaluate the efficacy of Saccharomyces boulardii against Giardia lamblia infections. A double-blind, placebo-controlled study was carried out on adult patients with giardiasis. Group 1 (30 patients) included metronidazole 750 mg 3 times daily along with S. boulardii capsules (250 mg b.i.d. orally) for 10 d while group 2 (35 patients) was treated with metronidazole 750 mg 3 times daily and with empty capsules as placebo for 10 d. Patients were re-examined at 2 and 4 weeks after treatment, and stool examinations were performed. At week 2, G. lamblia cysts were detected in 6 cases (17.1%) of group 2 and none in group 1. At the end of the fourth week, presence of the cysts continued in the same 6 cases in group 2 (control group). These findings indicated that S. boulardii may be effective in treating giardiasis when combined with metronidazole therapy.

Affiliations: 1: Department of Infectious Diseases and Clinical Microbiology, From the Gulhane Military Medical Academy, Ankara 2: Department of Infectious Diseases and Clinical Microbiology, Kutahya Military Hospital, Kutahya 3: Department of Microbiology, Gulhane Military Medical Academy, Ankara, Turkey

2. Influence of oral intake of Saccharomyces boulardii on Escherichia coli in enteric flora

Akil I, Yilmaz O, Kurutepe S, et al. Pediatr Nephrol 2006:21:807-810.

Enteric flora constitutes 95% of the cells in the human body. It has been shown that the bacterial content of this flora is affected by diet and changes in nutrition. Considering that urinary tract infections (UTI) are mostly due to ascending infections from the gut flora, the importance of the elements of this flora and their characteristics becomes more evident. The aim of this study was to evaluate the influence of oral Saccharomyces boulardii (S. boulardii) intake on the number of Escherichia coli (E. coli) colonies in the colon. This study was carried out with 14 boys and 10 girls (total of 24 children) aged between 36 and 192 months (mean: 104.345.1 months). A commercial capsule or powder containing 5 billion colony-forming units (cfu) of S. boulardii was administered once a day for 5 days. The number of E. coli and yeast colonies was measured in the stool samples of the study group before and after the use of this drug. Before treatment, the mean number of E. coli colonies in g/ml stool was 384,625445,744. This number decreased significantly to 6,28320,283 alter treatment (p = 0.00). S. boulardii was not detected in stool before treatment and the number of colonies increased to 11,04726,754 in g/ml stool. S. bonlardii may be effective in reducing the number of E. coli colonies in stool. The influence of this finding on clinical practice such as prevention of UTI needs to be clarified by further studies.

3. The probiotic effect of Saccharomyces boulardii in a pediatric age group

Erdeve O, Tiras U, Dallar Y. J Trop Pediatr 2004;50:234-236.

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.

4. Randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease.

McFarland LV, Surawicz CM, Greenberg RN, Fekety R, Elmer GW, Moyer KA, Melcher SA, Bowen KE, Cox JL, Noorani Z, et al.

Department of Medicinal Chemistry, School of Pharmacy, University of Washington, Seattle 98195.

OBJECTIVE--To determine the safety and efficacy of a new combination treatment for patients with Clostridium difficile-associated disease (CDD). The treatment combines the yeast Saccharomyces boulardii with an antibiotic (vancomycin hydrochloride or metronidazole). DESIGN--A double-blind, randomized, placebo-controlled, parallel-group intervention study in patients with active CDD. Patients received standard antibiotics and S boulardii or placebo for 4 weeks, and were followed up for an additional 4 weeks after therapy. Effectiveness was determined by comparing the recurrence of CDD in the two groups using multivariate analysis to control for other risk factors for CDD. SETTING--National referral study of ambulatory or hospitalized patients from three main study coordinating centers. PATIENTS--A total of 124 eligible consenting adult patients, including 64 who were enrolled with an initial episode of CDD, and 60 who had a history of at least one prior CDD episode. Patients who were immunosuppressed due to acquired immunodeficiency syndrome or cancer chemotherapy within 3 months were not eligible. INTERVENTION--Treatment with oral S boulardii (1 g/d for 4 weeks) or placebo in combination with a standard antibiotic. MAIN OUTCOME MEASURE--Recurrence of active CDD. RESULTS--A history of CDD episodes dramatically increased the likelihood of further recurrences. Multivariate analysis revealed that patients treated with S boulardii and standard antibiotics had a significantly lower relative risk (RR) of CDD recurrence (RR, 0.43; 95% confidence interval, 0.20 to 0.97) compared with placebo and standard antibiotics. The efficacy of S boulardii was significant (recurrence rate 34.6%, compared with 64.7% on placebo; P = .04) in patients with recurrent CDD, but not in patients with initial CDD (recurrence rate 19.3% compared with 24.2% on placebo; P = .86). There were no serious adverse reactions associated with S boulardii. CONCLUSIONS--The combination of standard antibiotics and S boulardii was shown to be an effective and safe therapy for these patients with recurrent CDD; no benefit of S boulardii was demonstrated for those with an initial episode of CDD.

5. Saccharomyces boulardii in maintenance treatment of Crohn's disease
Guslandi M, Mezzi G, Sorghi M, Testoni PA. Dig Dis Sci 2000;45:1462-1464.

The possible role of Saccharomyces boulardii, a nonpathogenic yeast with beneficial effects on the human intestine, in the maintenance treatment of Crohn's disease has been evaluated. Thirty-two patients with Crohn's disease in clinical remission (CDAI [is less than] 150) were randomly treated for six months with either mesalamine 1 g three times a day or mesalamine 1 g two times a day plus a preparation of Saccharomyces boulardii 1 g daily. Clinical relapses as assessed by CDAI values were observed in 37.5% of patients receiving mesalamine alone and in 6.25% of patients in the group treated with mesalamine plus the probiotic agent. Our results suggest that Saccharomyces boulardii may represent a useful tool in the maintenance treatment of Crohn's disease. However, in view of the product's cost, further controlled studies are needed to confirm these preliminary data.

Further References

McFarland, L.V. & Bernasconi, P. (1993) Saccharomyces boulardii: A Review of an Innovative Biotherapeutic Agent. Microbial Ecology in Health and Disease; Vol. 6 pp. 157-171.

Hochter, W. et al (1990) Saccharomyces boulardii in acute adult diarrhea. Efficacy and tolerance of treatment. Munchener Medizinische Wochenschrift; Vol. 132 (12) pp. 188-192.

Guillot, C. C. et al (1995) Effects of Saccharomyces boulardii in children with chronic diarrhea, especially cases due to Giardiasis. Revista Mexicana de Puericultura y Pediatra; Vol. 2: N°12.

Cetina-Sauri, G. & Basto, S. (1994) Therapeutic evaluation of Saccharomyces boulardii in children with acute diarrhea. Annales de Pediatrie; Vol. 41 (6) pp. 397-400.

Kirchhelle, A., Fruhwein, N. & Toburen, D. (1996) Treatment of persistent diarrhoea with Saccharomyces boulardii in returning travellers. Results of a prospective study; Fortschr Med; Vol. 114 (11) pp. 136-140.

Kurugol, Z. & Koturoglu, G. (2005) Effects of Saccharomyces boulardii in children with acute diarrhea. Acta Paediatrica; Vol. 94 pp. 44-47.