Table 1.
Study scheme
| Screening | Eradication treatment | Posteradication treatment | Follow-up | ||
| 14 d | 14 d | 28 d | |||
| Visit 1 (day −8 –[-1]) | Visit 2 (day 0) | Visit 3 (day 14) | Visit 4 (day 56 ± 3) | ||
| Postbiotic/Placebo taking | |||||
| Eradication treatment | |||||
| Demographics | + | ||||
| Medical history | + | ||||
| Complete blood count | + | + | |||
| Serum chemistry | + | + | |||
| Anti-HIV Ab, RPR, HBsAg, HCV-Ab | + | ||||
| Gastroscopy | + | ||||
| С-13 urease breath test for Helicobacter pylori | + | + | |||
| Pregnancy test | + | ||||
| Signing informed consent | + | ||||
| Checking inclusion and exclusion criteria | + | + | + | ||
| Randomization | + | ||||
| Initiation of eradication therapy for 14 d + postbiotic/placebo for 28 d | + | ||||
| 7 × 7 Questionnaire | + | + | + | ||
| GSRS questionnaire | + | + | + | ||
| SF-36 questionnaire | + | + | + | ||
| Assessment of adverse effects | + | + | |||
| Compliance assessment | + | ||||
GSRS, Gastrointestinal Symptom Rating Scale; RPR, rapid plasma reagin.