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Probiotics (Lactobacillus spp., Bifidobacterium spp., Saccharomyces boulardii)

Probiotic microorganisms

ATC code: A07FA-PROBIOTICS (Probiotic microorganisms (generic group) – local code)

Brand names – drugs

Florastor

Brand names – supplements

Culturelle, Garden of Life Dr. Formulated Probiotics

Supplements are not tested in clinical trials and are not registered as medications.

Mechanism of action

Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host (FAO/ 2002 definition). Mechanisms: competition with pathogenic flora for receptors and nutrients, short-chain fatty acid production, modulation of gut-associated lymphoid tissue immune responses, and epithelial barrier reinforcement. Effects are strain-specific: data on one Lactobacillus rhamnosus GG strain do not generalise to L. rhamnosus as a class.

Indications

B

Antibiotic-associated diarrhoea

Adjunct

The 2019 Cochrane review (33 RCTs, more than 6,000 children) showed a reduction in antibiotic-associated diarrhoea in children from 19% to 8% with high-dose probiotics (at least 5 billion CFU daily) from day 1 of antibiotic therapy. In adults, the effect is less pronounced. The best evidence is for Lactobacillus rhamnosus GG and Saccharomyces boulardii strains. 2020 recommends Saccharomyces boulardii or Lactobacillus + Bifidobacterium combinations for prevention in children.

The effect is strain-specific. Use products with confirmed strain identity and adequate dose, not “ordinary yoghurt”.

C

Irritable bowel syndrome

Individual decision

Cochrane 2019 and 2020 rated the evidence base for probiotics in IBS as moderate with high strain-dependence. Some meta-analyses showed reduced pain and bloating. AGA 2020 does not recommend probiotics for IBS in adults outside clinical trials due to result heterogeneity and study quality. In some IBS-D patients, Bifidobacterium infantis 35624 or combination preparations provide clinical improvement.

C

Prevention of Clostridioides difficile infection recurrence

Individual decision

Cochrane 2017 showed a reduction in CDI on antibiotic therapy with probiotic use. However, 2021 and 2020 do not give an unambiguous recommendation – results are inconsistent across strains, and probiotic-associated bacteraemia risk exists in immunocompromised patients. Standard recurrent CDI therapy: fidaxomicin, faecal microbiota therapy, bezlotoxumab.

D

Atopic dermatitis prevention in children

Individual decision

2015 gives a conditional recommendation in favour of probiotics in pregnant women with allergic history and their newborn infants for atopic dermatitis prevention. The effect is modest – about 10% absolute risk reduction. Most international allergy societies (, ) do not include probiotics in atopy prevention standards. Effects on food allergy or asthma prevention are not proven.

F

«Gut dysbiosis» as a standalone clinical diagnosis

Not recommended

«Gut dysbiosis» as a standalone diagnosis is absent from the international classification of diseases. , , , and WGO do not recognise it as a clinical entity and do not recommend «treating dysbiosis» with probiotics. In Russian practice the diagnosis is made by two methods, both problematic. First is stool culture, which does not reflect actual gut microbiota because 99 % of intestinal bacteria are strict anaerobes that do not grow on culture media. Second is the Osipov test (chromatography-mass spectrometry of microbial markers). The Russian Academy of Sciences in Memorandum No. 22 (2020) explicitly called this method pseudoscientific. Prescribing probiotics for a diagnosis that is not in the ICD, based on a test that the Academy considers pseudoscientific, has no evidence base.

F

Acne vulgaris (adjunctive therapy)

Not recommended

Probiotics do not work in acne. Acne Guidelines 2024 and EDF 2024 do not include probiotics. Systematic reviews show a few low-quality RCTs with small samples; the effect on acne severity and inflammatory lesion count is clinically insignificant. The «gut-skin axis» concept is heavily promoted in supplement marketing, but clinical evidence for acne treatment is absent. Standard acne therapy: topical retinoids, benzoyl peroxide, azelaic acid; topical or systemic antibiotics for moderate disease; isotretinoin for severe disease.

F

Autism spectrum disorder

Not recommended

Probiotics for autism spectrum disorder have no evidence base. The 2018 Cochrane review (Parracho HM et al.) and 2021–2023 updates showed no convincing effect on core ASD symptoms. The American Academy of Pediatrics and AACAP do not include probiotics in their recommendations. Core ASD interventions: behavioural therapy, communication programs, early intervention. Positioning probiotics as «autism treatment» in post-Soviet marketing is particularly dangerous because it distracts families from evidence-based interventions and financially exploits parents in difficult circumstances.

F

Major depressive disorder

Not recommended

«Psychobiotics» is a marketing term for probiotics positioned as treatment for depression and anxiety. , Mental Health, and WFSBP do not include probiotics in depression or anxiety recommendations. Small RCTs showed weak reductions in subjective anxiety scores in healthy students – this is not clinical depression treatment. Large RCTs in patients with established major depressive disorder did not show an effect. Standard depression therapy: CBT, SSRIs, SNRIs – not probiotics.

F

Prophylaxis of acute respiratory infections

Not recommended

Probiotics for boosting “general immunity” and preventing acute respiratory infections are not mentioned in international guidelines. Systematic reviews show a weak effect on respiratory infection incidence in children in daycare – clinically minor. In adults the effect is not confirmed. This positioning is marketing rather than scientific.

F

Weight loss in non-diabetics (marketed indication)

Not recommended

International guidelines do not include probiotics for weight loss. Systematic reviews (John GK et al. Genes 2018) showed an absolute weight reduction of 0.6 kg over 12 weeks, clinically insignificant. Endocrine Society, ACP, and AACE do not mention probiotics in obesity management. The «microbiome and weight» marketing relies on observational associations between bacterial profiles and obesity, but causality has not been established.

Practical notes

Timing and administration

Probiotics for antibiotic-associated diarrhoea prevention are started **on day 1 of antibiotic therapy**, not after its completion. This is the 2020 and Cochrane 2019 position: the effect is achieved when probiotics are taken in parallel with antibiotics. Postponing intake until «after the course» is pointless – the risk is already realised by then. Within the day, the probiotic capsule and antibiotic dose are separated by about 2 hours so that the antibiotic does not destroy probiotic bacteria in the gut at once. Continue the course for 1–2 weeks after antibiotic completion. Saccharomyces boulardii is a yeast – antibacterial drugs do not affect it; time separation is unnecessary.

Dose titration

Dose for prevention in children: 5–10 billion CFU daily. In adults: 10–20 billion CFU daily. Dose is measured in CFU (colony-forming units), not preparation mass. Compare products by strain identity and CFU dose, not by “bacteria count” in grams. Duration: throughout the antibiotic course plus 1–2 weeks.

Monitoring

No specific monitoring at standard doses. In immunocompromised patients (cancer, HIV, organ transplantation, severe neutropenia, central venous catheters), there is a risk of probiotic-associated bacteraemia and fungaemia. In this group, probiotic use is discussed with the treating clinician.

Food and drinks

Dietary probiotic sources: fermented dairy (live-culture yoghurt, kefir, ryazhenka), sauerkraut, kimchi, kombucha. CFU content in foods is lower than in preparations – ordinary yoghurt contains 100 million – 1 billion CFU per serving, 10 times less than the therapeutic dose.

Common myths

In post-Soviet medical practice probiotics are prescribed for a wide range of conditions without international evidence. Common misconceptions include the following.

Myth: «I have dysbiosis, so I need a probiotic course». Fact: «gut dysbiosis» as a standalone clinical diagnosis is absent from ICD-10 and ICD-11. , , , WGO do not recognise it. In Russian practice the diagnosis is made via stool culture – which does not reflect actual gut microbiota because 99 % of gut bacteria are strict anaerobes and do not grow on culture media. Or via the Osipov test (chromatography-mass spectrometry of microbial markers). The Russian Academy of Sciences in Memorandum No. 22 (2020) explicitly called this method pseudoscientific. «Treating dysbiosis» means treating a diagnosis that does not exist based on a test that does not work.


Myth: «the Osipov test showed which bacteria are missing, so I should supplement them via probiotics». Fact: the Osipov methodology is not recognised by the international scientific community. The 2020 Memorandum No. 22 of the Russian Academy of Sciences Commission Against Pseudoscience explicitly classifies the method as pseudoscientific. Test results lack clinical interpretation. If a clinician builds treatment on Osipov test results, a second opinion is warranted.


Myth: «probiotics restore microbiota after antibiotics». Fact: native microbiota recovers over 2–8 weeks regardless of probiotic intake. Probiotics reduce antibiotic-associated diarrhoea risk but do not restore microbiota composition. The 2018 Cochrane review showed no recovery effect in adults.


Myth: «probiotics treat acne through the gut-skin axis». Fact: Acne Guidelines 2024 and EDF 2024 do not recommend probiotics in acne. Clinical evidence is absent. Standard acne therapy: topical retinoids, benzoyl peroxide, systemic antibiotics, or isotretinoin when needed.


Myth: «probiotics aid weight loss». Fact: systematic reviews showed weight reduction of 0.6 kg over 12 weeks – clinically insignificant. Endocrine Society and other obesity societies do not include probiotics in recommendations.


Myth: «psychobiotics treat depression and anxiety». Fact: , Mental Health, and WFSBP do not include probiotics in depression or anxiety recommendations. The «gut-brain axis» marketing outpaces clinical evidence.


Myth: «probiotics improve the condition of children with autism». Fact: Cochrane 2018 and 2021–2023 updates did not show convincing effects on ASD symptoms. and AACAP do not support the practice. Positioning probiotics as «autism treatment» is financial exploitation of families and distraction from evidence-based interventions (behavioural therapy, early intervention).


Myth: «more strains in the bottle means better effect». Fact: effects are strain-specific. «Multi-strain complexes of 15 cultures» are marketing. Clinical RCTs tested specific strains: Lactobacillus rhamnosus GG, Saccharomyces boulardii, Bifidobacterium infantis 35624. Data on one strain do not transfer to others.


Myth: «probiotics are absolutely safe for everyone». Fact: in immunocompromised patients and people with central venous catheters there is a risk of bacteraemia and fungaemia. In severe acute pancreatitis, the multicentre PROPATRIA RCT 2008 showed increased mortality with probiotic use.

Safety

Contraindications

  • Severe immunodeficiency (haematological malignancies, advanced HIV/AIDS, severe neutropenia)
  • Central venous catheters
  • Severe acute pancreatitis (per PROPATRIA RCT – increased mortality)
  • Hypersensitivity to components

Serious adverse effects

  • Probiotic-associated bacteraemia (Lactobacillus, Bifidobacterium) in immunocompromised patients
  • Fungaemia (Saccharomyces boulardii) in patients with central venous catheters
  • Endocarditis in patients with prosthetic heart valves (case reports)

Common adverse effects

  • Flatulence, abdominal discomfort in the first days
  • Mild diarrhoea or constipation (adaptive response)

Uncommon adverse effects

  • Allergic reactions
  • Skin rash

PregnancyFDA B

Safe in standard doses during pregnancy. Use for atopic dermatitis prevention in newborns from allergy-predisposed families is discussed with a clinician.

Breastfeeding

Safe during breastfeeding. Do not transfer systemically from the maternal GI tract.

Reviewed: 4/19/2026

Updated: 4/19/2026