In the US, nutraceuticals are marketed under the Dietary Supplement and Health Education Act of 1994 (DSHEA). Consequently, scientific data supporting claimed benefit(s) are not always available for nutraceuticals as they are for traditional pharmaceuticals since nutraceuticals are not regulated as drugs. Consumers should also note that rigid quality control standards are not required for nutraceuticals and substantial variability can occur in both the potency and the purity of these products. Monographs on nutraceuticals are included in CP when reliable clinical data are available. The information presented below is condensed from the best clinical data we could find.
The yeast species Saccharomyces boulardii is a different species from the Brewer's yeast species of S. cerevisiae or S. carlsbergensis (also known as S. pastorianus). This yeast is non-pathogenic in most persons, is not a normal inhabitant of the human bowel microflora, and is found naturally on the skin of certain fruits, such as lychee fruit and mangosteens. The probiotic preparations of Saccharomyces boulardii are purported to reestablish the normal physiologic and bacterial flora of the intestinal tract. The products are administered orally as dietary supplements to support intestinal health, and are used off-label in the treatment of uncomplicated diarrhea, particularly that caused by modification of the intestinal flora by antibiotics. Although not FDA-approved drug products and regulated as dietary supplements, probiotic products of Saccharomyces boulardii (e.g., Florastor products) have seen widespread in clinical use, following some controlled trials of its success in preventing antibiotic associated diarrhea (AAD). Along with Lactobaccilus sp., Saccharomyces boulardii has also been used as a co-strategy in prevention of clostridium difficile associated diarrhea (CDAD) and infection, particularly in relapsed cases. A "lyo" suffix after the species name in the ingredient of select products refers to lyophilization of the yeast in product preparation. Preterm neonates who receive probiotics are at risk of invasive, potentially fatal disease caused by the bacteria or fungi contained in probiotics. Microorganisms contained in probiotics have been reported in the medical literature as causing bacteremia or fungemia, sometimes with a severe clinical course, in very preterm or very low birthweight (VLBW) neonates.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
Oral Solid Formulations
-Health care workers should follow standard infection control practices; after handling Saccharomyces boulardii products, gloves, if worn, should be discarded. Hands should be thoroughly cleansed. These practices will prevent transfer of the yeast inadvertently to patients.
-NOTE: Warning: To avoid unintentional systemic introduction of the Saccharomyces yeast and resultant fungemia, do not open capsules or granule packets, crush, or otherwise handle Saccharomyces boulardii products in the vicinity of patients with central lines. This includes long-term central venous catheters (CVCs), peripherally inserted central catheters (PICC lines), and central access implantable devices (ports).
-See specific product labeling for administration and storage.
-Capsules: Swallow capsules whole or mix contents of capsule with water, apple juice or other non-carbonated drinks. Capsule contents can also be added to apple sauce and other soft foods.
-Granules: May administer contents of the granule packet directly onto the tongue of the patient. May also mix contents of granule packet with water, apple juice, or other non-carbonated drinks. For babies, may add to formula after warmed. Can also be added to apple sauce and other soft baby foods.
-Chewable tablets: Chew well, then swallow. May be given before or after a meal. For individuals who cannot chew, the tablets may be crushed and sprinkled onto the tongue or added to a beverage or soft food.
-Prepare only as needed for immediate administration. The products are only viable for 30 minutes after preparation in food or beverages.
-Do NOT mix with hot beverages (above 122 degrees F) or with alcoholic beverages or foods.
Saccharomyces boulardii is reported to be generally well tolerated in immunocompetent patients. According to the supplement manufacturer, less than 1% of patients report constipation or thirst (polydipsia) as side effects. Some published articles have infrequently reported (1 to 10% of patients) intestinal gas or flatulence as a side effect. In patients with a yeast or protein intolerance, rare cases of nausea and vomiting might occur, or other symptoms associated with such food intolerances or allergies. Probiotics are regulated as dietary supplements, rather than as drugs, so studies often lack detail of reported adverse reactions to these products and manufacturers are not required to report adverse events to the FDA in a systematic fashion.
Saccharomyces boulardii, when administered orally to immunocompetent patients, is normally a non-pathogenic yeast. Saccharomyces fungemia infection secondary to use of the probiotic Saccharomyces boulardii has been described for patients who are critically ill, are receiving nutrition enterally or parenterally, are immunosuppressed (e.g., receiving cancer treatment), or have a central venous catheter. The medical literature contains published reports of over 55 cases of such events, and although the overall incidence of this fungemia is very rare, it may lead to sepsis. In reported cases, the occurrence of a new or continuing fever along with clinical suspicion led to the diagnosis of fungemia; some cases have been resistant to azole antifungals and have required agents such as caspofungin for treatment. Initially, it was difficult to isolate specific Saccharomyces yeast strains when fungemia was suspected; however, the ability to reliably determine whether administered probiotic strains match the clinical isolate is now possible through DNA-based methods. Before use of a probiotic is considered for hospitalized patients, careful assessment of risk versus benefit must be made. Patients who have compromised immune status and the critically ill may be more susceptible to infectious risks, which may be caused by intestinal translocation or colonization or contamination of systemic access devices. To ensure patient safety, the probiotic should be properly handled during administration, which includes preparation of dosage outside the patient's room, and with proper infection control practices to prevent inadvertent spread of infection. The manufacturers include a contraindication in the product labels for use in patients with central line placements.
Saccharomyces boulardii lyo (Florastor product line) is a single strain of yeast, and therefore is contraindicated for use in patients with a yeast allergy. There may be trace amounts of soy in the Florastor products.
Saccharomyces boulardii is contraindicated for use in patients with a central venous catheter placement. When administered orally, Saccharomyces boulardii is normally a non-pathogenic yeast. However, systemic fungal infection has occurred in patients with central venous access when the product powder has inadvertently attached to a central line. To avoid unintentional systemic introduction of the Saccharomyces yeast and resultant fungemia, do not open capsules or granule packets in the vicinity of patients with central lines. This includes long-term central venous catheters (CVCs), peripherally inserted central catheters (PICC lines), and central access implantable devices (ports).
Saccharomyces boulardii is not recommended for use in patients with immunosuppression, including those with acquired immunodeficiency syndrome (AIDS). When administered orally, Saccharomyces boulardii is normally a non-pathogenic yeast. However, systemic fungal infection has occurred in select patients with inadvertent systemic exposure, and immunosuppressed patients are more likely to be at risk for unintended infection.
Specific information regarding safety of Saccharomyces boulardii use in pregnancy is lacking; the FDA has not assigned pregnancy risk ratings to dietary supplements of probiotics, as they are not regulated as drugs. There are no reliable animal data regarding fetal effects. Pregnant women should get the advice and approval of their qualified health care provider prior to use and should not self treat or supplement. Use should occur, as with most supplements and medicines, when the benefit of maternal use exceeds any potential fetal risk.
There are no data regarding the use of Saccharomyces boulardii products during breast-feeding and caution is advised, though maternal probiotic use is possibly safe during breast-feeding for healthy infants over 2 months of age. Some probiotic strains have been reported to be excreted in breast milk. It is not known if Saccharomyces boulardii is found in breast milk. Use during lactation may not be advisable if the nursing infant is less than 2 months old, is premature (neonatal prematurity) or if the infant is immunosuppressed or has GI disease affecting the integrity of the GI tract due to potential infection risk (see Adverse Reactions). Self-supplementation with probiotics is not advised during lactation and the mother should seek advice of her qualified health care professional prior to use.
Avoid use of Saccharomyces boulardii in infants younger than 2 months of age, in neonates, or in premature neonates. Premature neonates who receive probiotics are at risk of invasive, potentially fatal disease caused by the bacteria or fungi contained in probiotics. Microorganisms contained in probiotics have been reported in the medical literature as causing bacteremia or fungemia, sometimes with a severe clinical course, in very preterm or very low birthweight (VLBW) neonates. A preterm neonate, birthweight less than 1,000 grams, who was administered a probiotic (Evivo with MCT Oil) as part of in-hospital care developed sepsis caused by the bacterium Bifidobacterium longum and subsequently died. Genomic sequencing data demonstrated the bacterium that caused sepsis in this neonate was a genetic match to the bacteria contained in this probiotic. Certain dosage forms, such as chewable tablets and capsules, may represent a choking hazard in young children and infants; take care in selection of dosage forms.
The Florastor products of Saccharomyces boulardii also contain lactose and should be used with caution in patients with lactase deficiency. The amount of lactose present per serving is roughly the same amount in 1/3 of a slice of cheese. The probiotic effects of the supplement may help boost lactose tolerance, so it is unclear if patients with lactase deficiency will observe any ill effect from supplement use.
For the prevention or treatment of uncomplicated diarrhea* due to antibiotic usage or for nutritional supplementation to support intestinal health and support normal physiologic bacterial flora of the intestinal tract in immunocompetent patients:
Oral dosage:
Adults, Adolescents, Children and Infants: Refer to the specific product labeling for suggested dosing unless otherwise directed by healthcare practitioner. Dosing varies between manufacturers. Twice daily administration has been the dosage used in clinical trials for prevention or as an adjunct to antibiotic treatment of antibiotic associated diarrhea (AAD), including relapsed C. difficile associated diarrhea (CDAD).
Maximum Dosage Limits:
-Adults
Refer to the specific product labeling for suggested dosing unless otherwise directed by healthcare practitioner.
-Geriatric
Refer to the specific product labeling for suggested dosing unless otherwise directed by healthcare practitioner.
-Adolescents
Refer to the specific product labeling for suggested dosing unless otherwise directed by healthcare practitioner.
-Children
Refer to the specific product labeling for suggested dosing unless otherwise directed by healthcare practitioner.
-Infants
Refer to the specific product labeling for suggested dosing unless otherwise directed by healthcare practitioner.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
Amphotericin B: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Anidulafungin: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Antifungals: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Fluconazole: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Flucytosine: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Griseofulvin: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Ibrexafungerp: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Isavuconazonium: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Itraconazole: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Ketoconazole: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Micafungin: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Posaconazole: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Terbinafine: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Voriconazole: (Major) Because Saccharomyces boulardii is an active yeast, it would be expected to be inactivated by any antifungals. The manufacturer does not recommend taking in conjunction with any antifungal agents. Patients should avoid use of this probiotic yeast until the fungal or yeast infection is completely treated.
Probiotics are defined as microorganisms, which when given in adequate amounts alter the microflora by implantation or colonization in a compartment of the host and confer a health benefit on the host. The probiotic preparations of Saccharomyces boulardii are purported to reestablish the normal physiologic and bacterial flora of the intestinal tract.
Saccharomyces boulardii supplements are administered orally; precise pharmacokinetic data are not available. Systemic exposure to the organism is possible via catheter access, such as exposure of opened capsules or the powder to central lines.