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. 2020 Mar 6;9(3):e15759. doi: 10.2196/15759

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.