Table 1

Timetable of activities planned during the study

 Study period
EnrolmentAllocationPostallocation
Antibiotic therapy
Close-out (after the end of follow-up period)
Time pointDay 1Day 1Day 2Day 3Day 4Day 5Every day
Enrolment
 Eligibility screenX
 Informed consentX
 Randomisation of the participantX
 Study product distributionX
 Diary of symptomsX
Interventions
Lactobacillus reuteri DSM 17938
 Placebo
Assessments
 Adverse eventsXXXXXX
 Stool analysis in case of diarrhoea/AADXXXXXX
 Daily diary reportingXXXXXX
 Telephone contact to check diary reporting and compliance in outpatientsXXXXXX
 Return of non-used study productsX
  • AAD, antibiotic-associated diarrhoea.