Fecal Microbiota Transplantation Effect on Amyotrophic Lateral Sclerosis Patients

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.

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

Sponsors & Collaborators

• University of Modena and Reggio Emilia

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Campus Bio-Medico University

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• Azienda Ospedaliera di Perugia

  collaborator OTHER

• University of Chieti

  collaborator OTHER

• University of Florence

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Modena

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-01

Primary Completion

2024-10-31

Completion

2025-02-28

Countries

• Italy

Study Locations