Bolardi250 mg (5 billion CFU)

Bolardi is a non-pathogenic probiotic yeast used mainly as an adjunct in the prevention and management of diarrheal conditions.

Guideline/evidence-supported uses

• Prevention of antibiotic-associated diarrhea (AAD): Taken alongside a course of antibiotics to reduce the risk of diarrhea.
• Adjunctive management of acute infectious diarrhea (including acute gastroenteritis in children), used together with oral rehydration therapy (ORT), not as a replacement for it.

Adjunct / off-label uses with supporting evidence

• Prevention of recurrent Clostridioides difficile-associated diarrhea, used as an adjunct alongside appropriate antibiotic therapy, under medical supervision.
• Prevention of traveler's diarrhea in some populations, with more limited evidence.

Bolardi is intended as adjunctive therapy and does not replace fluid/electrolyte replacement or antibiotics where these are indicated. A physician should determine the most appropriate use for an individual patient.

Each capsule/sachet contains lyophilized (freeze-dried) Saccharomyces Boulardii, commonly standardized to 250 mg equivalent to not less than 5 x 10^9 viable colony-forming units (CFU), along with pharmaceutically acceptable excipients. Strength and CFU count can vary by brand/formulation.

Bolardi is a non-pathogenic, tropical probiotic yeast (unrelated to Saccharomyces cerevisiae used in baking/brewing in its clinical strain characteristics) that is naturally resistant to gastric acid and to most antibiotics, allowing it to survive transit through the upper gastrointestinal tract.

It is supplied as a lyophilized powder in capsules or sachets and acts locally within the gut lumen; it does not undergo systemic absorption and is eliminated from the stool within a few days after the last dose.

Bolardi belongs to the Probiotic agents class, used as an antidiarrheal adjunct.

Saccharomyces Boulardii exerts several complementary local actions within the gastrointestinal tract:

• Anti-toxin effect: Produces a protease that degrades Clostridioides difficile toxins A and B and reduces the effects of certain other bacterial enterotoxins.
• Trophic effect: Increases activity of brush-border disaccharidase enzymes and supports enterocyte function, aiding recovery of the intestinal mucosa.
• Anti-inflammatory/barrier effect: Reduces pro-inflammatory signaling in the gut mucosa and helps maintain tight-junction integrity.
• Immune modulation: Stimulates secretory IgA production, supporting mucosal defense.
• Antimicrobial competition: Competes with pathogenic organisms for attachment sites and nutrients.

Saccharomyces Boulardii is not systemically absorbed; it acts within the gut lumen and is cleared from the body in the stool within 2-5 days of discontinuation.

Bolardi capsules should be swallowed whole with water. Sachets should be opened and the powder dissolved in a small amount of cool or lukewarm liquid, milk, or soft food and consumed immediately. Avoid hot beverages/food and alcoholic drinks as a vehicle, since heat and alcohol can kill the live yeast. Wash hands before and after administration, especially in a hospital setting or when caring for patients who have a central venous catheter (see Precautions and Warnings).

Bolardi has the following notable interactions:

• Systemic or oral antifungal medicines (e.g., fluconazole, itraconazole, ketoconazole, amphotericin B): May reduce the viability and effectiveness of Bolardi since it is a live yeast organism; if concurrent use is necessary, doses should be spaced apart and a physician consulted.
• Immunosuppressive therapy: Concomitant use in significantly immunosuppressed patients increases the theoretical risk of yeast translocation/fungemia (see Contraindications and Precautions).

No clinically significant interactions with common antibiotics, antacids, or standard oral rehydration solutions have been established; Bolardi is often specifically co-administered with antibiotics for prevention of antibiotic-associated diarrhea.

Bolardi is generally well tolerated in healthy individuals.

Common side effects

• Flatulence (gas)
• Mild abdominal bloating or discomfort
• Increased thirst (uncommon)

Rare but serious side effects (seek medical attention)

• Allergic reactions (rash, itching, swelling, difficulty breathing).
• Saccharomyces fungemia (bloodstream yeast infection) - reported rarely, almost exclusively in critically ill, immunocompromised patients or those with a central venous catheter (see Contraindications).

Pregnancy: Data on the use of Bolardi during pregnancy are limited. As with any medicine or supplement, Bolardi should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk; a physician should be consulted before use.

Lactation: There is limited specific data on Bolardi use during breastfeeding. Since it acts locally in the gut and is not systemically absorbed, significant transfer into breast milk is not expected, but a physician should be consulted before use during breastfeeding.

• Central venous catheters: Bolardi should be avoided in patients with a central venous line, and capsules should not be opened near a catheter insertion site or in the immediate patient-care area, as airborne yeast particles have rarely been linked to catheter contamination and fungemia. Healthcare staff and caregivers should wash hands thoroughly after handling capsules/sachets.
• Immunocompromised and critically ill patients: Avoid use in patients who are severely immunosuppressed, critically ill, or in intensive care, due to increased fungemia risk (see Contraindications).
• Not a substitute for rehydration: Bolardi is an adjunct to, not a replacement for, oral rehydration therapy and any antibiotics or other treatment indicated for the underlying cause of diarrhea.
• Concurrent antifungal use: May reduce effectiveness of Bolardi (see Interactions).
• Seek medical care if diarrhea is severe, bloody, persistent beyond a few days, or accompanied by high fever, signs of dehydration, or severe abdominal pain.

Bolardi has a wide margin of safety in healthy individuals, and significant toxicity from excessive intake has not been well characterized. Taking more than the recommended amount may increase the likelihood of mild gastrointestinal effects such as bloating or flatulence.

If a large overdose is taken, or if any concerning symptoms develop (especially in an immunocompromised patient or one with a central venous catheter), seek immediate medical attention or contact a poison control center. Management is supportive and should be provided by a healthcare professional.

Store at room temperature (below 25-30°C), in a cool, dry place away from heat, light, and moisture. Do not store near hot surfaces. Some formulations may recommend refrigeration after opening - check the specific product label. Keep out of reach of children.

Pediatric patients

Bolardi is commonly used in children above 1 year of age as an adjunct for acute diarrhea and antibiotic-associated diarrhea prevention, with dosing adjusted by the treating pediatrician; safety and efficacy in infants under 1 year are not well established (see Pediatric Uses).

Elderly

No specific dose adjustment is required for elderly patients, though caution is warranted if significant comorbid immunosuppression or a central venous catheter is present.

Renal/hepatic impairment

No dose adjustment is required, as Bolardi acts locally in the gut and is not systemically absorbed or metabolized by the liver or kidneys.

Immunocompromised patients and those with central venous catheters

Bolardi should be avoided in these populations due to fungemia risk (see Contraindications).

Pregnancy and breastfeeding

See Pregnancy and Lactation section.

For acute infectious diarrhea, Bolardi is typically used for 5-7 days alongside oral rehydration therapy. For prevention of antibiotic-associated diarrhea, it is usually started at the same time as the antibiotic and continued for about one week after the antibiotic course ends. When used as an adjunct for recurrent C. difficile-associated diarrhea, duration is determined by the treating physician based on the antibiotic regimen being used. Treatment duration should always be individualized by a physician.

Probiotic (Antidiarrheal adjunct)

Saccharomyces Boulardii is a non-pathogenic probiotic yeast that acts locally within the intestinal lumen rather than being systemically absorbed. It produces a protease enzyme that degrades Clostridioides difficile toxins A and B, competes with pathogenic organisms for adhesion sites and nutrients, supports intestinal brush-border enzyme (disaccharidase) activity, helps maintain intestinal barrier/tight-junction integrity, reduces pro-inflammatory signaling in the gut mucosa, and stimulates secretory IgA production to support mucosal immune defense. It is naturally resistant to gastric acid and to most antibiotics (but not to antifungal agents), which allows it to remain viable through the gastrointestinal tract during antibiotic therapy. It is cleared from the body in the stool within a few days of stopping treatment.

Bolardi is commonly used in children above 1 year of age as an adjunct for the prevention of antibiotic-associated diarrhea and for management of acute infectious diarrhea, together with oral rehydration therapy, under a pediatrician's guidance. Dosing in children is generally lower (around 250 mg once or twice daily) and should be adjusted for the child's age and weight. Safety and efficacy in infants younger than 1 year, and in preterm or medically fragile infants, have not been well established, and use in this group should only be considered under close medical supervision, particularly because case reports of fungemia have occurred rarely in vulnerable, hospitalized infants.