Safety of Saccharomyces boulardii (Florastor) in Solid Organ Transplant Patients

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1 Butler University Digital Butler University Undergraduate Honors Thesis Collection Undergraduate Scholarship Safety of Saccharomyces boulardii (Florastor) in Solid Organ Transplant Patients Nicole Marie Dores Butler University Follow this and additional works at: Part of the Medicinal and Pharmaceutical Chemistry Commons Recommended Citation Dores, Nicole Marie, "Safety of Saccharomyces boulardii (Florastor) in Solid Organ Transplant Patients" (2012). Undergraduate Honors Thesis Collection This Thesis is brought to you for free and open access by the Undergraduate Scholarship at Digital Butler University. It has been accepted for inclusion in Undergraduate Honors Thesis Collection by an authorized administrator of Digital Butler University. For more information, please contact

2 BUTLER UNIVERSITY HONORS PROGRAM Honors Thesis Certification Please type all information in this section: Applicant Nicole Marie Dores (Name as it is to appear on diploma) Thesis title Safety of Saccharomyces boulardii (Florastor ) in Solid Organ Transplant Patients Intended date of commencement May 12, Read, approved, and signed by: Thesis adviser(s)~4l Reader(s)..tLhUi2~ J/1/9t;~, date Date Certified by if ~.t4 -:MI L Date For Honors Program use: Level of Honors conferred: University Ma~VlIA (um LavaL Departmental 'Pnd(WlACY W(tltl I1ljhtsf HVl10CS V V)lversi tv fhm(}3 PfP (4 WI

3 Safety of Saccharomyces boulardii (Florastor ) in Solid Organ Transplant Patients A Thesis Presented to the Department of Pharmacy Practice College of Pharmacy and Health Sciences and The Honors Program of Butler University In Partial Fulfillment of the Requirements for Graduation Honors Nicole Marie Dores May 4,2012

4 Abstract Introduction: Probiotics have been promoted for use in many gastrointestinal ailments. Most studies find probiotics safe for human use, reporting no severe adverse effects. However, probiotics are live microorganisms and thus have the potential to cause infection. Transplant recipients are considered at high risk for infectious complications from probiotics due to the immunosuppressive medications used to prevent organ rejection. Nonetheless, clinicians are currently utilizing probiotics in the transplant population, due to their benefit in gastrointestinal disorders, particularly recurrent Clostridium difficile. Limited knowledge and paucity of prospective trials in this patient population demands the need for completion of studies to identify the safety of probiotics in transplant patients. Objective: The primary objective of this study was to investigate the safety of utilizing Saccharomyces boulardii for the prevention of antibiotic-associated diarrhea in kidney, pancreas, and liver transplant recipients. A secondary obj ective of this study was to evaluate the efficacy of the use of Saccharomyces boulardii to prevent antibiotic-associated diarrhea. Methods: A prospective chart review was performed to assess the safety of Saccharomyces boulardii in transplant patients. All kidney, pancreas, and liver transplant patients who received Saccharomyces boulardii were included in the safety analysis. Only those who meet criteria for the prevention of antibiotic-associated diarrhea with Saccharomyces boulardii were included in the efficacy analysis. 1

5 Results: No infections due to the probiotic, Saccharomyces boulardii, in 16 solid organ transplant patients treated were observed. Conclusion: There are multiple of case reports regarding infectious complications of probiotics, particularly in groups at high risk for infection. However, some studies have shown probiotics given immediately after transplantation may help restore normal gut flora and prevent the translocation of bacteria across the gut wall thereby preventing infections in these immunosuppressed patients. This study found no infectious complications of probiotics in solid organ transplant recipients. 2

6 Introduction: The World Health Organization and the Food and Agriculture Organization of the United Nations define probiotics as "live microorganisms which when administered in adequate amounts confer a heath benefit to the host."1 In recent years, probiotics have been promoted for use in many disease states. In the hospital setting, probiotics are mainly used to replenish the colon microflora in patients with diarrhea due to antibiotics or to prevent recurrence of disease following treatment of Clostridium difficile colitis. 2 Most studies have found probiotics safe for human use, reporting no severe adverse effects. However, probiotics are live microorganisms and have the potential to cause infection. Patients at a higher risk of developing infection from probiotic therapy include those with immunosuppressed states, critical or terminal illness, prosthetic heart valves, bowel surgery, history of rheumatic heart disease or infective endocarditis, or use of proton pump inhibitors or histamine H2 antagonists. These higher risk patients are often excluded from probiotic studies limiting knowledge concerning the safety of probiotic therapy in these populations.y'r' Organ transplant recipients are considered a high risk group for infectious complications from probiotic therapy due to the administration of immunosuppressive medications used to prevent organ rejection." Conversely, some studies have shown probiotics beneficial in restoring normal gut flora and preventing the translocation of bacteria across the gut wall and thereby preventing infections in these immunosuppressed patients. 7,8 There are no previous prospective trials regarding the use of a Saccharomyces probiotic in the solid organ transplant population. The primary objective of this study was to investigate the safety of using Saccharomyces boulardii for the prevention of antibiotic- 3

7 associated diarrhea in solid organ transplant recipients. A secondary objective of this study was to evaluate the efficacy of the use of Saccharomyces boulardii to prevent antibioticassociated diarrhea. Methods All patients> 18 years of age who were recipients of a simultaneous kidney/pancreas, pancreas after kidney, isolated pancreas or liver transplant and were initiated on Saccharomyces boulardii therapy while admitted to the organ transplant unit at Indiana University Hospital from July 1,2011 to March 1,2012 were eligible for this prospective study. Patients who were pregnant, had a known hypersensitivity to Saccharomyces spp., or received other probiotics prior to admission were excluded. Following approval from the Indiana University School of Medicine Institutional Review Board, data was collected from the electronic medical record including age, sex, admission diagnosis, medical history, concomitant information, illness, documented infection via culture results, probiotic administration and results of tests for Clostridium difficile. Clinical outcomes data was also collected which included incidence of diarrhea or constipation, infectious complications, and other serious adverse effects associated with the probiotic therapy. Data was assessed using descriptive statistics. All patients were included in the safety analysis to determine the incidence of infectious complications due to Saccharomyces boulardii. Those patients who received antibiotic therapy as well as Saccharomyces boulardii and no other probiotic were included in the efficacy analysis to determine the benefit of Saccharomyces boulardii for the prevention of antibiotic associated diarrhea. 4

8 Results: Sixteen patients received probiotics with no documented infections or other serious complications. The demographics of the patient population are shown in Table 1. Five of these patients met the criteria for efficacy analysis of prevention of antibiotic-associated diarrhea with Saccharomyces boulardii. Three of these patients experienced diarrhea. Two had been admitted with diarrhea and found to have Clostridiums difficile colitis and were treated with either the standard of care for Clostridium difficile colitis (metronidazole or vancomycin) in addition to the Saccharomyces boulardii. Both patients had resolution of their diarrhea with this treatment. The other patient experienced diarrhea after 5 days of probiotic therapy. The probiotic was continued and due to improvement of diarrhea the patient was discharged on the probiotic. Discussion: In this study, Saccharomyces boulardii therapy was well tolerated in pancreas, kidney, and liver transplant patients with no serious adverse effects. Although this was a small study, it contradicts literature showing infectious complications of probiotics particularly in patients who are immunosuppressed. Current guidelines for the prevention and treatment of Clostridium difficile infection from the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America state "administration of currently available probiotics is not recommended to prevent primary Clostridium difficile infection, as there are limited data to support this approach and there is a potential risk of bloodstream infection.,,9 These guidelines also discourage the use of Saccharomyces spp. therapy; "administration of Saccharomyces boulardii has, however, been associated with fungemia in 5

9 immunocompromised patients and in patients with central venous lines, and should be avoided in critically ill patients.?" These recommendations are based on case reports that describe infectious complications of probiotics in groups at risk for infection. In a review of 92 cases of invasive infections due to Saccharomyces spp., Saccharomyces boulardii was responsible for 37 fungemias.i" Of these patients, 32 had taken a probiotic that contained Saccharomyces boulardii. Those who had a Saccharomyces boulardii infection were more likely to have a digestive tract disease, a central venous catheter, and be hospitalized in an intensive care unit. 10 Munoz, and colleagues, II investigated an outbreak of Saccharomyces cerevisiae fungemias in an intensive care unit. The investigators revealed the commonality between the three patients with fungemia was treatment with a Saccharomyces boulardii probiotic, brand name Ultralevura. Both the probiotic strain of yeast and the blood cultures isolated from the three patients were identified by the hospital microbiology laboratory as Saccharomyces cerevisiae with identical DNA fingerprinting. Discontinuation of the probiotic product ended further infections in the unit. II Like critically ill patients, organ transplant recipients are considered high risk for infectious complications of probiotics. The purported reason suggested for this increased risk of infectious complications in transplant recipients is the immune compromised state induced from the transplant medications required to prevent rejection of the transplanted organ." Luong and colleagues 12 report their experience in which a 56-year-old male with human immunodeficiency virus underwent a double-lung transplant and developed an empyema which cultured positive for Lactobacillus rhamnosus GG, the strain of bacteria 6

10 identical to the probiotic administered as part of the standard post-transplant Clostridium difficile prophylaxis regime. 12 Riquelme and colleagues'< report a case ofa 42-year-old woman, having received a kidney-pancreas transplant developed Saccharomyces cerevisiae fungemia after treatment with Saccharomyces boulardii for Clostridium difficile. Though the strain of Saccharomyces spp. was S. cerevisiae and not S. boulardii, the investigators concluded the fungemia was a result of the administration of the probiotic as it is very difficult for most laboratories to distinguish Saccharomyces boulardii from Saccharomyces., 13 cerevtsiae. In our study, conclusions regarding efficacy cannot be made due to the limited number of patients meeting the inclusion criteria at this time. Trials have shown benefit with the use of probiotics for diarrhea. In a study conducted by Hickson and colleagues.!" 135 older adults taking antibiotics were randomized to receive either a probiotic drink containing Lactobacillus casei, Lactobacillus bulgaricus, and Streptococcus thermophilus or a sterile milkshake. The incidence of both antibiotic-associated and Clostridium difficile diarrhea was decreased in the probiotic group. In a review of probiotics by Imhoff and Karpa, 15 a tendency towards benefits from probiotics was observed. Clinical trials of probiotics containing multiple strains were shown to be most favorable for primary prevention of Clostridium difjicile associated disease. However, clinical trials and case reports of the probiotic Saccharomyces boulardii in combination with high-dose vancomycin were most advantageous for the prevention of recurrence di 2,15 isease. Current guidelines for the use of nutritional support in critical ill patients from the Society of Critical Care Medicine and the American Society for Parenteral and Enteral 7

11 Nutrition state, "administration of probiotic agents has been shown to improve outcome (most consistently by decreasing infection) in specific critically ill patient populations involving transplantation, major abdominal surgery, and severe trauma.v'" However, the guidelines do not recommend one probiotic strain or combination over another. "It seems that each species may have different effects and variable impact on patient outcome, making it difficult to make broad categorical recommendations." 16 Rayes and colleagues 7,8 have shown the administration of probiotics immediately after transplantation may help restore normal gut flora and prevent translocation of bacteria across the gut wall thus preventing infections in these immunosuppressed patients. In a group of 66 adult liver transplant patients, those patients treated with a probiotic containing Pediacoccus pentosaceus, Leuconostoc mesenteroides, Lactobacillus paracasei, and Lactobacillus plantarum twice daily for 14 days immediately post-transplantation showed a significant decrease in post-operative infections. Post-operative infections were seen in 48% of patients who did not receive probiotic therapy and 3% of patients who received probiotic therapy.' Conclusion: Although the use ofprobiotics in solid organ transplant recipients and other immunocompromised individuals is controversial, they are still utilized in these populations. This prospective trial found no infectious complications with the administration of the probiotic Saccharomyces boulardii in sixteen solid organ transplant patients. Further research is required to determine the safety of probiotics, including Saccharomyces boulardii, in the solid organ transplant population. 8

12 References: 1. FAO/WHO. Guidelines for the evaluation ofprobiotics in food. Food and Agriculture Organization of the United Nations Web site: ftp://ftp.fao.org/es/esn/food/wgreport2.pdf. Published Accessed June 24, McFarland LV, Surawicz CM, Greenberg RN et al. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. JAMA.1994;271(24): Wallace B. Clinical use ofprobiotics in the pediatric population. Nutr Clin Pract. 2009;24(1): Rohde CL, Bartolini V, Jones N. The use ofprobiotics in the prevention and treatment of antibiotic-associated diarrhea with special interest in Clostridium d~fficile-associated diarrhea. Nutr Clin Pract. 2009;24(1): Lawrence SJ, Korzenik JR, Mundy LM. Probiotics for recurrent Clostridium difficile disease. J Med Microbiol. 2005;54: Boyle RJ, Robins-Browne RM, Tang ML. Probiotic use in clinical practice: what are the risks? Am J Clin Nutr. 2006;83(6): Rayes N, Seehofer D, Theruvath T, et al. Supply of pre- and probiotics reduces bacterial infection rates after liver transplantation--a randomized, double-blind trial. Am J Transplant. 2005;5(1): Rayes N, Seehofer D, Hansen S, et al. Early enteral supply of Lactobacillus and fiber versus selective bowel decontamination: a controlled trial in liver transplant recipients. Transplantation. 2002;74(1):

13 9. Cohen SH, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for health care epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Ho,sp Epidemiol. 2010;31(5): Enache-Angoulvant A, Hennequin C. Invasive Saccharomyces infection: a comprehensive review. Clin Infect Dis. 2005;41(11): Munoz P, Bouza E, Cuenca-Estrella M, et al. Saccharomyces cerevisiae fungemia: an emerging infectious disease. Clin Infect Dis. 2005;40(11): Luong ML, Sareyyupoglu B, Nguyen MH, et al. Lactobacillus probiotic use in cardiothoracic transplant recipients: a link to invasive Lactobacillus infection? Transpl Infect Dis. 2010;12(6): Riquelme A, Calvo MA, Guzman AM, et al. Saccharomyces cerevisiae fungemia after Saccharomyces boulardii treatment in immunocompromised patients. J Clin Gastroenterol. 2003;36(1): Hickson M, D'Souza AL, Muthu Net al. Use of pro biotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomized double blind placebo controlled trial. BMJ. 2007;335(7610): Imhoff A, Karpa K. Is there a future for probiotics in preventing Clostridium difficileassociated disease and treatment of recurrent episodes? Nutr Clin Pract. 2009;24(1):

14 16. Martindale RG, McClave SA, Vanek VW, et al. Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition: Executive Summary. Crit Care Med. 2009;37(5):

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