Table 3.
Study flow chart.
| Pre-treatment | Treatment | Follow up | Study end | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Examinations | Screening | Baseline (W0) | FMT 1 (Rome) | M1 | M3 | M6 | FMT 2 (Rome) | M7 | M9 | M12 (Rome) | M12 |
| Time window | <3 weeks from screening | <4 weeks from screening | ±3 days | ±3 days | ±3 days | ±7 days | ±7 days | ±7 days | ±7 days | ≥7 days <4 weeks from M12 | |
| Informed consent | x | ||||||||||
| Medical history | x | ||||||||||
| Inclusion exclusion criteria | x | ||||||||||
| Patient able to understand and follow procedures | x | ||||||||||
| FMT | x | x | |||||||||
| CLINICAL ASSESSMENT | |||||||||||
| Neurological examination | x | x | x | x | x | x | x | x | |||
| ALSFRS-R | x | x | x | x | x | x | x | x | |||
| FVC | x | x | x | x | x | x | x | x | |||
| MRC | x | x | x | x | x | x | x | x | |||
| BMI | x | x | x | x | x | x | x | x | x | x | x |
| SAFETY ASSESSMENT | |||||||||||
| Adverse events | x | x | x | x | x | x | x | ||||
| Vital signs | x | x | x | x | x | x | x | x | x | x | x |
| Physical examination | x | x | x | x | x | x | x | x | x | x | x |
| Concomitant medications | x | x | x | x | x | x | x | x | x | x | x |
| Chest X-ray | x (1) | ||||||||||
| ECG | x (1) | ||||||||||
| Hematology | x | x | x | x | x | x | x | ||||
| Biochemistry | x | x | x | x | x | x | x | ||||
| Urinalysis | x | x | x | x | x | x | x | ||||
| Pregnancy test | x | ||||||||||
| Infectious markers | x | ||||||||||
| Fecal calprotectin | x | x | x | ||||||||
| BIOLOGICAL ACTIVITY | |||||||||||
| Treg | x | x | x | x | x | x | x | ||||
| Lymphocytes phenotype | x | x | x | x | |||||||
| Fecal and saliva samples (microbiota) | x | x | x | ||||||||
| Gut tissue | x | x | x | ||||||||
| CSF | x | x | |||||||||
| Peripheral biomarkers | x | x | x | x | x | ||||||
| QUALITY OF LIFE ASSESSMENT | |||||||||||
| ALSAQ40 | x | x | x | ||||||||
(1) If not done at diagnosis or in the last 12 months.
FMT, Fecal Microbial Transplantation; M, Month; MRC, Medical Research Council; FVC, Forced Vital Capacity; BMI, Body Mass Index; ALSFRS-R, Revised ALS Functional Rating Scale; ECG, Electrocardiogram; CSF, Cerebrospinal Fluid; ALSAQ40, ALS Specific Assessment Questionnaire; W, week..