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NCT03766321

Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients

Sponsor: Azienda Ospedaliero-Universitaria di Modena

View on ClinicalTrials.gov

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 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.

Official title: Interplay Between Gut Microbiota and Adaptive Immunity in Amyotrophic Lateral Sclerosis: a Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-07-01

Completion Date

2025-02

Last Updated

2024-08-27

Healthy Volunteers

Conditions

Amyotrophic Lateral Sclerosis

Interventions

BIOLOGICAL

Fecal microbiota transplantation

Fecal microbiota transplantation will be performed during two endoscopic procedures (baseline and at 6 months) by allogenic infusion of collected feces in the duodenum-jejunum.

BIOLOGICAL

Placebo

patients will undergo endoscopic procedure with biopsy during sedation but without any kind of intervention

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

Locations (5)

Clinica Neurologica, Ospedale Clinicizzato "SS Annunziata"

Chieti, Italy

Azienda Ospedaliero Universitaria di Modena

Modena, Italy

UO Neurofisiopatologia, Azienda Ospedaliera dì Perugia

Perugia, Italy

Catholic University of Sacred Heart - Fondazione Policlinico "A. Gemelli"

Roma, Italy

NEuroMuscular Omnicentre Centre (NeMO), Fondazione Serena Onlus-Fondazione Policlinico A. Gemelli