“Gut dysbiosis” as a standalone clinical diagnosis
«Gut dysbiosis» as a standalone clinical diagnosis is absent from ICD-10 and ICD-11. International gastroenterology societies (AGA, ACG, BSG, WGO) do not recognise it as a clinical entity. In Russian practice it is diagnosed by stool culture or by the Osipov test (chromatography-mass spectrometry of microbial markers). Stool culture does not reflect gut microbiota (the lower GI tract contains 99 % strict anaerobes that do not grow on culture media). The Russian Academy of Sciences in Memorandum No. 22 (2020) declared the Osipov test pseudoscientific. The term «dysbiosis» is used in scientific literature to describe microbiota changes, but it is not a clinical diagnosis or an indication for treatment.
Also known as: Intestinal dysbiosis as a standalone diagnosis
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.
- FMesalazineNot recommended · Locally acting intestinal aminosalicylateMesalazine (5-aminosalicylic acid, 5-ASA) is an anti-inflammatory drug for inflammatory bowel disease. It is prescribed for ulcerative colitis and Crohn's disease with colonic involvement (ACG 2024, ECCO 2024). For intestinal dysbiosis, mesalazine is not indicated: dysbiosis is not recognized as an independent diagnosis in immunocompetent people in international medicine, with no agreed diagnostic criteria. The drug has specific risks: nephrotoxicity (requires renal function monitoring), hepatotoxicity, myocarditis and pericarditis (rare), pancreatitis, and severe skin reactions. If mesalazine was prescribed for dysbiosis outside ulcerative colitis or Crohn's disease, consider seeking a second opinion.
- FProbiotics (Lactobacillus spp., Bifidobacterium spp., Saccharomyces boulardii)Not recommended · Probiotic microorganisms«Gut dysbiosis» as a standalone diagnosis is absent from the international classification of diseases. AGA, ACG, BSG, 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.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- 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