Table 1.
Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) schedule of enrollment, interventions, and assessments.
Protocol items | Study period | ||||||
|
|
Screening (day -3 to -1) | Enrollment (day 0) | Assessment and allocation (day 0) | Study diets (days 2-7) | First follow-up (days 14±3) | Second follow-up (days 21±3) |
Enrollment |
|
|
|
|
|
|
|
|
Eligibility screen |
|
x |
|
|
|
|
|
Informed consent |
|
x |
|
|
|
|
|
Randomization and allocation |
|
|
x |
|
|
|
Interventions |
|
|
|
|
|
|
|
|
Different diets |
|
|
x | x |
|
|
Assessments |
|
|
|
|
|
|
|
|
Demographics | x |
|
|
|
|
|
|
Comorbidities | x |
|
|
|
|
|
|
Physical examinations | x |
|
|
x | x | x |
Primary outcome |
|
|
|
|
|
|
|
|
Resolution of diarrhea (by day 5) |
|
|
|
x |
|
|
Secondary outcomes |
|
|
|
|
|
|
|
|
Resolution of diarrhea (by day 7) |
|
|
|
x |
|
|
|
Consistency of stool |
|
|
|
x |
|
|
|
Frequency of stool |
|
|
|
x |
|
|
|
Recovery time |
|
|
|
x |
|
|
|
Hospital-acquired infection |
|
|
|
x |
|
|
|
Relapse at first follow-up |
|
|
|
|
x |
|
|
Relapse at second follow-up |
|
|
|
|
|
x |
|
Enteric pathogen detection by TaqMan assaya | x |
|
|
|
|
|
|
Detection of gut microbiota by 16S rRNA sequencinga |
|
x |
|
x |
|
|
|
Detection of proteomes and metabolomes from blooda |
|
x |
|
x |
|
|
aAccording to the addendum (Ethical Committee approval on May 5, 2018), at the end of the study, stored stool samples and blood samples will be processed for the desired testing.