Interplay between gut microbiota and adaptive immunity in amyotrophic lateral sclerosis: a clinical trial

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