Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients
- Conditions
- Amyotrophic Lateral Sclerosis
- Registration Number
- NCT03766321
- Lead Sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria:<br><br> - Patients diagnosed with a laboratory supported, clinically probable or definite<br> amyotrophic lateral sclerosis according to the Revised El Escorial criteria (Brooks,<br> 2000)<br><br> - Sporadic or familial ALS<br><br> - Female or male patients aged between 18 and 70 years old<br><br> - Disease duration from symptoms onset no longer than 18 months at the screening visit<br><br> - Patients treated with a stable dose of Riluzole (100 mg/day) for at least 30 days<br> prior to screening<br><br> - Patients with a weight > 50 kg and a BMI =18<br><br> - Patients with a FVC (Forced Vital Capacity) equal or more than 70% predicted normal<br> value for gender, height, and age at the screening visit<br><br> - Patients able and willing to comply with study procedures as per protocol<br><br> - Patients able to understand, and capable of providing informed consent at screening<br> visit prior to any protocol-specific procedures<br><br> - Use of effective contraception both for males and females<br><br>Exclusion Criteria:<br><br> - Known organic gastrointestinal disease<br><br> - History of gastrointestinal malignancy; ongoing malignancies<br><br> - Use of immunosuppressive or chemotherapy within the past 2 years<br><br> - Celiac disease and/or food (e.g.lactose) intolerance<br><br> - Previous gastrointestinal surgery<br><br> - Any condition that would make endoscopic procedures contraindicated<br><br> - Acute infections requiring antibiotics<br><br> - Antimicrobial treatment or probiotics 4 weeks prior to screening<br><br> - Severe comorbidities (heart, renal, liver failure); severe renal (eGFR<<br> 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST > 2x Upper<br> limit of normal),<br><br> - Autoimmune diseases, inflammatory disorders (SLE, Rheumatoid arthritis, connective<br> tissue disorder) or chronic infections (HIV, hepatitis B or C infection)<br><br> - Abuse of alcohol or drugs<br><br> - HIV, tuberculosis, hepatitis<br><br> - Participation in clinical trials <30 days before screening<br><br> - Existing blood dyscrasia (e.g., myelodysplasia)<br><br> - White blood cells<4,000/mm³, platelets count<100,000/mm³, hematocrit<30%<br><br> - Patients who underwent non-invasive ventilation, tracheotomy and /or gastrostomy<br><br> - Women who are pregnant or breastfeeding
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Tregs number
- Secondary Outcome Measures
Name Time Method Change in T cell subsets frequency in blood and gut tissue samples;Change in heavy neurofilaments levels in CSF;Changes in levels of pro-inflammatory cytokines and cytokines linked to T cell proliferation and differentiation;Changes in microbiota profile;Incidence of Adverse Events;Tracheostomy free survival;Forced vital capacity (FVC);disease progression;quality of life: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)