Status:
ACTIVE_NOT_RECRUITING
Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Collaborating Sponsors:
University of Modena and Reggio Emilia
Catholic University of the Sacred Heart
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Given the role of adaptive immunity in ALS, the pathogenicity of some clostridial strains on motorneurons, the putative role of cyanobacteria in ALS development, and the increasing interest for microb...
Detailed Description
The study will include 42 ALS patients with 2:1 allocation in 2 groups of subjects (28 FMT vs 14 placebo); computerized randomization will be stratified by progression rate (ΔFS) \</≥0.7. Randomizatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03766321
Start Date
July 1 2020
End Date
February 1 2025
Last Update
August 27 2024
Active Locations (5)
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1
Clinica Neurologica, Ospedale Clinicizzato "SS Annunziata"
Chieti, Italy
2
Azienda Ospedaliero Universitaria di Modena
Modena, Italy
3
UO Neurofisiopatologia, Azienda Ospedaliera dì Perugia
Perugia, Italy
4
Catholic University of Sacred Heart - Fondazione Policlinico "A. Gemelli"
Roma, Italy