Schedule of activities
| Procedures | Screening Day −1 to 0 | Enrolment/ baseline visit 1, day 1 | Study visit 2–9* | Study visit 10† Day 10±1 day | Study visit 11–1‡ Days 11–69±2 days | Final study visit 18 Day 70±7 days |
| Informed consent | X | |||||
| Demographics | X | |||||
| Medical history | X | |||||
| Randomisation | X | |||||
| Administer study intervention | X | X | X | |||
| Concomitant medication review | X | X | ||||
| Physical examination | X | X | X | |||
| Haematology | X | X | X | |||
| Complete metabolic panel | X | X | X | |||
| CRP, ESR, serum cytokines | X | X | X | |||
| Adverse event review and evaluation | X | X | ||||
| Faecal TcdB, tcdB, lactoferrin, cytokines | X | X | X | |||
| Collect stool for microbiome and urine for metabolomics | X | X | X | |||
| Complete case report forms | X | X | X | X | X | X |
*Daily visits while in the hospital or phone calls, if discharged.
†Participant comes to the clinic for assessment and specimen collection, if discharged.
‡Weekly calls, if discharged; participant may be seen any day of the week (M–F) for episodes of diarrhoea, if not yet seen by other healthcare providers; stools will be collected for C. difficile testing, if not yet done.
CRP, C-reactive protein; ESR, erythrocyte sedimentation rate.