Table 1 Timetable of activities planned during the study
Study period | ||||||
|---|---|---|---|---|---|---|
Enrolment and allocation | Post allocation | Close-out (after the end of follow-up period) | ||||
Time point | Day 1 | Month 3 | Month 6 | Month 9 | Month 12 | |
Enrolment | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Randomisation of the participant | X | |||||
Study product distribution | X | |||||
Interventions | ||||||
Probiotic | ||||||
Placebo | ||||||
Assessments | ||||||
Recurrence of UTI | X | X | X | X | X | |
Frequencies of hospitalization due to UTI | X | X | X | X | X | |
No of days of antibiotic therapy due to UTI | X | X | X | X | X | |
Return of patient’s diary | X | |||||
Return of non-used study products | X | |||||
Telephone contact* | X | x | X | X | ||