Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients

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.

NCT Number	NCT03766321
Lead Sponsor	Azienda Ospedaliero-Universitaria di Modena Collaborators: University of Modena and Reggio Emilia, Catholic University of the Sacred Heart, Campus Bio-Medico University, Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliera di Perugia, University of Chieti, University of Florence
Conditions	Amyotrophic Lateral Sclerosis
Enrollment	42 participants
Start Date	2020-07-01
Primary Completion	2024-10 (estimated)
Study Completion	2025-02 (estimated)
Updated on ClinicalTrials.gov	2024-08-27