Table 1.

Inclusion and exclusion criteria for the SacBo trial

Inclusion criteria:

adult patient (≥18 years old) hospitalized in the trial center systemic antibiotic treatment legally competent able to follow the trial procedures signed informed consent

Exclusion criteria:

hypersensitivity to yeast and/or Perenterol® forte and/or placebo and/or its ingredients: Saccharomyces cerevisiae HANSEN CBS 5926 (boulardii), lactose-monohydrate, magnesium stearate, gelatin, sodium dodecyl sulfate, titanium dioxide, microcrystalline cellulose central venous catheter (currently or likely during the course of the trial) immunosuppression, particularly: known malignant tumor or current cytostatic chemotherapy or chemotherapy planned during the antibiotic intake or cytostatic chemotherapy within the last 4 weeks; radiation therapy in the past 4 weeks, current or planned during the course of the antibiotic treatment; systemic immunosuppressive treatment (i.e. after organ transplant or with rheumatic disorder) – topical or inhaled steroids were permitted; known HIV infection current and/or chronic diarrhea regular intake of products containing Sac. boulardii in the 7 days before inclusion into the trial systemic antimycotic treatment systemic antibiotic treatment in the past 6 weeks no birth control for the duration of the trial for women of reproductive age (failure proportion <1%/year), pregnancy, or breastfeeding simultaneous participation in other clinical trials