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Saccharomyces boulardii CNCM I-745

AEMPS

Yeast probiotic. AEMPS registered Enterol (Biocodex) as a medicinal product for AAD, travellers diarrhoea and adjunct therapy for C. difficile

ATC code: A07FA-SBOULARDII

Brand names – supplements: Now Saccharomyces Boulardii, Jarrow Saccharomyces Boulardii + MOS, Thorne SacroB, FlorastorSupplements are not tested in clinical trials and are not registered as medications.

Updated · Methodology

Indications

B

Antibiotic-associated diarrhoea

First line

S. boulardii CNCM I-745 is one of the most studied probiotics with convincing evidence in antibiotic-associated diarrhoea. AEMPS registered Enterol (Biocodex) with the indication of prevention and treatment in adults and children. McFarland 2010 (meta-analysis of 31 RCTs) showed AAD risk reduction with S. boulardii added to antibiotic therapy, RR ~0.53. Cochrane Goldenberg 2017 included S. boulardii among first-choice strains (alongside LGG). ESPGHAN 2014 in children on antibiotics lists S. boulardii and LGG as options with confirmed efficacy. 2020 does not routinely recommend probiotics in adults but allows them in C. difficile high-risk groups (elderly, hospitalised, broad-spectrum antibiotic users). Dose: 250–500 mg twice daily from antibiotic day 1, continued 7 days after antibiotic completion.

Sources

  1. Cochrane: Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children (2017)
  2. World J Gastroenterol: Systematic review and meta-analysis of Saccharomyces boulardii in adult patients (2010)
  3. ESPGHAN: Use of probiotics for the management of acute gastroenteritis (2014)
  4. AEMPS / CIMA: Enterol 250 mg cápsulas duras (Saccharomyces boulardii CNCM I-745) – ficha técnica (2024)

ICD-10: K52.9 · ICD-11: ME05.1

C

Acute infectious diarrhea

Adjunct

S. boulardii is used as adjunct in acute infectious gastroenteritis. ESPGHAN 2014 in children with acute gastroenteritis lists S. boulardii and LGG as options with confirmed efficacy for modest diarrhoea duration reduction (~1 day). After negative Schnadower 2018 and Freedman 2018 RCTs for LGG, 2020 revised its position and does not routinely recommend probiotics in acute infectious gastroenteritis. Distinction: S. boulardii has a separate evidence base with less negative results, but no PECARN-level RCTs have been conducted. Primary therapy for acute gastroenteritis is oral rehydration (ORS); for severe dehydration – intravenous infusion. S. boulardii may be considered as adjunct for moderate diarrhoea without dehydration signs but not as substitute for rehydration.

Sources

  1. ESPGHAN: Use of probiotics for the management of acute gastroenteritis (2014)
  2. AGA: AGA clinical practice guidelines on the role of probiotics in the management of gastrointestinal disorders (2020)

ICD-10: A09 · ICD-11: 1A40

C

Travelers' diarrhea

Adjunct

AEMPS registered Enterol with the indication of travellers diarrhoea prevention in adults. McFarland 2010 meta-analysis included several travellers diarrhoea RCTs with moderate episode frequency reductions on prophylactic S. boulardii 500–1000 mg/day 5 days before and during travel to endemic regions. Effect is modest and incomplete – does not replace basic food and water safety practices. ISTM 2017 states: probiotics are an option for low/medium risk; for high risk – discussion of ciprofloxacin or rifaximin where indicated. For established travellers diarrhoea, primary therapy is oral rehydration; for bacterial aetiology – azithromycin or ciprofloxacin. S. boulardii may be used as adjunct, not as substitute.

Sources

  1. World J Gastroenterol: Systematic review and meta-analysis of Saccharomyces boulardii in adult patients (2010)
  2. AEMPS / CIMA: Enterol 250 mg cápsulas duras (Saccharomyces boulardii CNCM I-745) – ficha técnica (2024)

ICD-10: A09 · ICD-11: 1A40

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Irritable bowel syndrome

Not recommended

S. boulardii is offered for irritable bowel syndrome, especially IBS-D after acute gastroenteritis (post-infectious IBS). Small RCTs showed heterogeneous results. 2021 IBS guideline gives a conditional recommendation against routine probiotic use in adult IBS. S. boulardii has no specific IBS indication in AEMPS registration dossier (Enterol registered only for and travellers diarrhoea). If S. boulardii was recommended for IBS as monotherapy without discussing diet, low-FODMAP approach and red flags (weight loss, nocturnal symptoms, bloody stool, onset after 50), consider seeking a second opinion from a gastroenterologist.

Sources

  1. ACG: ACG clinical guideline: management of irritable bowel syndrome (2021)

ICD-10: K58.8 · ICD-11: DD91.0Z

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Saccharomyces boulardii CNCM I-745 is a non-pathogenic yeast strain isolated by Henri Boulard in 1923 from lychee and mangosteen peel in Indochina. Principal difference from bacterial probiotics: the yeast cell is resistant to most antibiotics (except antifungals) and transits the GI tract without suppression during concomitant antibiotic therapy. Mechanisms from laboratory and animal models: protease production inactivating C. difficile toxins A and B, competition with pathogens for intestinal epithelium receptors, increased sIgA and anti-inflammatory IL-10 cytokine secretion. Naturally eliminated from the gut 3–5 days after discontinuation. Cochrane Goldenberg 2017 included S. boulardii among strains with confirmed efficacy.

Safety

Contraindications

  • Immunodeficiency (AIDS-stage HIV, post-chemotherapy neutropenia, after organ and bone marrow transplant) – fungaemia risk
  • Central venous catheter – Saccharomyces fungaemia cases reported with mortality up to 30%
  • Critically ill patients in intensive care
  • Severe acute pancreatitis
  • Hypersensitivity to yeast and formulation components

Serious adverse effects

  • Fungaemia (Saccharomyces fungaemia) in patients with central catheter, immunodeficiency, critically ill – mortality up to 30%, requires fluconazole or caspofungin and catheter removal
  • Endocarditis (rare reports)
  • Allergic reactions to yeast protein (urticaria, angiooedema, anaphylaxis – rare)
  • Masking of C. difficile colitis, delaying adequate antibacterial therapy

Common adverse effects

  • Abdominal bloating, flatulence
  • Constipation (paradoxical, in first days)
  • Thirst
  • Pruritus (rare)

Pregnancy: can you take Saccharomyces boulardii CNCM I-745?

In pregnancy, S. boulardii is permitted on indication. AEMPS Enterol SmPC: use in pregnancy only when clearly needed. No fungaemia cases in pregnant women reported.

Breastfeeding: can you take Saccharomyces boulardii CNCM I-745?

Compatible with breastfeeding. Yeast cells do not enter systemic circulation and do not transfer to milk.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

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Frequently asked

What is Saccharomyces boulardii CNCM I-745 used for?

Saccharomyces boulardii CNCM I-745 is evaluated for the following indications with varying evidence strength: Antibiotic-associated diarrhoea (evidence tier B), Acute infectious diarrhea (evidence tier C), Travelers' diarrhea (evidence tier C). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Saccharomyces boulardii CNCM I-745?

Common side effects of Saccharomyces boulardii CNCM I-745 (≥ 1 in 100): Abdominal bloating, flatulence, Constipation (paradoxical, in first days), Thirst, Pruritus (rare). See the Safety section for uncommon and serious reactions.

Is Saccharomyces boulardii CNCM I-745 safe during pregnancy?

In pregnancy, S. boulardii is permitted on indication. AEMPS Enterol SmPC: use in pregnancy only when clearly needed. No fungaemia cases in pregnant women reported.

Is Saccharomyces boulardii CNCM I-745 compatible with breastfeeding?

Compatible with breastfeeding. Yeast cells do not enter systemic circulation and do not transfer to milk.

Who should not take Saccharomyces boulardii CNCM I-745?

Saccharomyces boulardii CNCM I-745 is contraindicated in: Immunodeficiency (AIDS-stage HIV, post-chemotherapy neutropenia, after organ and bone marrow transplant) – fungaemia risk; Central venous catheter – Saccharomyces fungaemia cases reported with mortality up to 30%; Critically ill patients in intensive care; Severe acute pancreatitis; Hypersensitivity to yeast and formulation components. Full list in the Safety section.

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