INTRODUCTION: Several studies have demonstrated dysbiosis in irritable bowel syndrome (IBS). Therefore, faecal microbiota transplantation, whose effect and safety have been proven in Clostridioides difficile infections, may hold promise in other conditions, including IBS. Our study will examine the effectiveness of stool transfer with artificially increased microbial diversity in IBS treatment. METHODS AND ANALYSIS: A three-group, double-blind,randomised, cross-over, placebo-controlled study of two pairs of gut microbiota transfer will be conducted in 99 patients with diarrhoeal or mixed type of IBS. Patients aged 18-65 will be randomised into three equally sized groups: group A will first receive two enemas of study microbiota mixture (deep-frozen stored stool microbiota mixed from eight healthy donors); after 8 weeks, they will receive two enemas with placebo (autoclaved microbiota mixture), whereas group B will first receive placebo, then microbiota mixture. Finally, group C will receive placebos only. The IBS Severity Symptom Score (IBS-SSS) questionnaires will be collected at baseline and then at weeks 3, 5, 8, 11, 13, 32. Faecal bacteriome will be profiled before and regularly after interventions using 16S rDNA next-generation sequencing. Food records, dietary questionnaires, anthropometry, bioimpedance, biochemistry and haematology workup will be obtained at study visits during the follow-up period. The primary outcome is the change in the IBS-SSS between the baseline and 4 weeks after the intervention for each patient compared with placebo. Secondary outcomes are IBS-SSS at 2 weeks after the intervention and 32 weeks compared with placebo and changes in the number of loose stools, Bristol stool scale, abdominal pain and bloating, anthropometric parameters, psychological evaluation and the gut microbiome composition. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Thomayer University Hospital, Czechia (G-18-26); study results will be published in peer-reviewed journals and presented at international conferences and patient group meetings. TRIAL REGISTRATION NUMBER: NCT04899869.

• MeSH
• dysbióza terapie   MeSH
• fekální transplantace metody   MeSH
• klinické křížové studie MeSH
• lidé MeSH
• mikrobiota * MeSH
• průjem terapie   MeSH
• randomizované kontrolované studie jako téma MeSH
• syndrom dráždivého tračníku * terapie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• protokol klinické studie MeSH

Normalizations of gene expression data are commonly used in practice. They are used for removing systematic variation which affects the measure of gene expression levels. But one can object to the using of normalized data for testing hypotheses. By using normalized data, tests can break nominal level of multiple testing on which we would like to test the hypotheses. It could bring a lot of false positives, which we would like to prevent. In this chapter, by simulating data with similar correlation structure as real data, we try to find out how quantile, global, and δ-sequence normalizations hold the nominal level of Bonferroni multiple testing procedure.

• MeSH
• algoritmy MeSH
• interpretace statistických dat * MeSH
• lidé MeSH
• normální rozdělení MeSH
• počítačová simulace MeSH
• sekvenční analýza hybridizací s uspořádaným souborem oligonukleotidů metody   MeSH
• stanovení celkové genové exprese metody   MeSH
• statistické modely MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH