Can donor gut bacteria reshape the immune system in ALS?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients diagnosed with a laboratory supported, clinically "probable" or "definite" amyotrophic lateral sclerosis according to the Revised El Escorial criteria (Brooks, 2000) * Sporadic or familial ALS * Female or male patients aged between 18 and 70 years old * Disease duration from symptoms onset no longer than 18 months at the screening visit * Patients treated with a stable dose of Riluzole (100 mg/day) for at least 30 days prior to screening * Patients with a weight \> 50 kg and a BMI ≥18 * Patients with a FVC (Forced Vital Capacity) equal or more than 70% predicted normal value for gender, height, and age at the screening visit * Patients able and willing to comply with study procedures as per protocol * Patients able to understand, and capable of providing informed consent at screening visit prior to any protocol-specific procedures * Use of effective contraception both for males and females Exclusion Criteria: * Known organic gastrointestinal disease * History of gastrointestinal malignancy; ongoing malignancies * Use of immunosuppressive or chemotherapy within the past 2 years * Celiac disease and/or food (e.g.lactose) intolerance * Previous gastrointestinal surgery * Any condition that would make endoscopic procedures contraindicated * Acute infections requiring antibiotics * Antimicrobial treatment or probiotics 4 weeks prior to screening * Severe comorbidities (heart, renal, liver failure); severe renal (eGFR\< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST \> 2x Upper limit of normal), * Autoimmune diseases, inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infections (HIV, hepatitis B or C infection) * Abuse of alcohol or drugs * HIV, tuberculosis, hepatitis * Participation in clinical trials \<30 days before screening * Existing blood dyscrasia (e.g., myelodysplasia) * White blood cells\<4,000/mm³, platelets count\<100,000/mm³, hematocrit\<30% * Patients who underwent non-invasive ventilation, tracheotomy and /or gastrostomy * Women who are pregnant or breastfeeding