Table 1.
Time points of the outcomes assessment.
|
|
Screening (T-1)a | Intervention | Follow up (T20) | ||||||||||
|
|
|
T0 | T4 | T8 | T12 |
|
|||||||
| Inclusion criteria | ✓ |
|
|
|
|
|
|||||||
| Exclusion criteria | ✓ |
|
|
|
|
|
|||||||
| Informed consent | ✓ |
|
|
|
|
|
|||||||
| Randomization |
|
✓ |
|
|
|
|
|||||||
| Outcomes | |||||||||||||
|
|
MFI-20b | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
|
|
SF-36c | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
|
|
PSQId | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
|
|
GSRSe | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
|
|
HADSf | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
|
|
fMRIg |
|
✓ |
|
|
✓ |
|
||||||
|
|
gut microbiota |
|
✓ |
|
|
✓ |
|
||||||
|
|
peripheral blood |
|
✓ |
|
|
✓ |
|
||||||
aT0-T20: Time.
bMFI-20: Multidimensional Fatigue Inventory 20.
cSF-36: Short Form 36-item Health Survey.
dPSQI: Pittsburgh Sleep Quality Index.
eGSRS: Gastrointestinal Symptom Rating Scale.
fHADS: Hospital Anxiety and Depression Scale.
gfMRI: functional magnetic resonance imaging.