Table 1.
Assessment | Screening visit: Day –28 to 0a | Baseline visit: Day –7 to 0a | Visit at 3 months | Visit at 12 months | Visit at 24 months | Unscheduled visit (<10 days of relapse) |
Informed consent | Xb | |||||
Inclusion and exclusion criteria check | X | X | ||||
Demography | Yc | |||||
Medical history | Y | |||||
Height | Y | |||||
Weight | Y |
|
|
Y |
|
|
Vital signs | Y | X | Y | Y | Y | |
Bristol Stool Scale |
|
X | X | X | X |
|
Disease assessment: Expanded Disability Status Scale (EDSS) | X |
|
X | X | X | X |
Magnetic resonance imaging (MRI): brain | Y | Y | X | |||
Oral swab |
|
X | X | X | X |
|
Stool sample collection for microbiota assessment | X | X | X | X | ||
Blood sampling for immunological assessment | X | X | X | X | ||
Concomitant medication | Y |
|
Y | Y | Y | Y |
Adverse events | Y | Y | Y | Y | Y | |
Food registration by patient | X | X | X | X |
aScreening and baseline visit activities can be performed on the same day.
bX: study-specific assessment.
cY: routine assessment.