NCT03766321Completed
Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients
Interplay Between Gut Microbiota and Adaptive Immunity in Amyotrophic Lateral Sclerosis: a Clinical Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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 microbiota in neurodegenerative disorders, the modification of intestinal microbiota might affect ALS at its core. This interventional study aims at evaluating the biological and disease-modifying effects of Fecal Microbiota Transplant (FMT) in patients affected by Amyotrophic Lateral Sclerosis. As a primary aim of the study, the investigators postulate ALS patients treated with FMT compared to the control arm will display increased Tregs number, which is a favourable biomarker of disease activity and progression. Clinical outcomes as disease progression measured by ALS Functional Rating Scale Revised (ALSFRS-R) score, survival, respiratory function and quality of life will be assessed during the whole treatment and follow-up period. Moreover, biological activity of FMT will be evaluated in different biomatrices, together with FMT safety and tolerability in a cohort of ALS patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 30 Nov 2018
- Start date
- 1 Jul 2020
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT03766321
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 1 Jul 2020 to the primary completion date, 1 Feb 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of immunosuppressive or chemotherapy within the past 2 years
- Previous gastrointestinal surgery
- Antimicrobial treatment or probiotics 4 weeks prior to screening
- Abuse of alcohol or drugs
- Participation in clinical trials \<30 days before screening
Other illness
- Known organic gastrointestinal disease
- History of gastrointestinal malignancy; ongoing malignancies
- Celiac disease and/or food (e.g.lactose) intolerance
- Any condition that would make endoscopic procedures contraindicated
- Acute infections requiring antibiotics
- Autoimmune diseases, inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infections (HIV, hepatitis B or C infection)
- HIV, tuberculosis, hepatitis
Lab values
- 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),
- White blood cells\<4,000/mm³, platelets count\<100,000/mm³, hematocrit\<30%
Other
- Existing blood dyscrasia (e.g., myelodysplasia)
- Patients who underwent non-invasive ventilation, tracheotomy and /or gastrostomy
- Women who are pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Neurologica, Ospedale Clinicizzato "SS Annunziata" Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| UO Neurofisiopatologia, Azienda Ospedaliera dì Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| NEuroMuscular Omnicentre Centre (NeMO), Fondazione Serena Onlus-Fondazione Policlinico A. Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Catholic University of Sacred Heart - Fondazione Policlinico "A. Gemelli" Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.