About this trial

The aim of this study is to assess the impact of a probiotic formulation on participants with ALS-FTDSD. It is hypothesized that participants given the probiotics will have different lipid profiles compared to participants receiving the placebo at different time points.

Eligibility criteria

Qualifiers

Aged 18 years old or greater.

Diagnosis of ALS by El Escorial Criteria revised (possible, probable, probable with lab support and definite).

Onset of weakness or speech impairment no more than 24 months before randomization.

ALSFRS-R equal or superior to 24/48 at screening, with no more than one subscore under 2/4.

Disqualifiers

Use of respiratory support (non-invasive ventilation or mechanical respiratory support) at screening.

Significant medical condition or behavioral issues that could interfere with participation in the clinical trial in the principal investigator's opinion.

Use of a feeding tube at randomization.

Use of lipid-lowering drugs for less than 3 months before randomization.

Trial design

Treatments tested in this trial

  • Probiotic
  • Placebo

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

3
Stan Cassidy Centre for RehabilitationE3B 0C7, FrederictonNew Brunswick, Canada
Centre Hospitalier de l'Université de MontréalH2X 0A9, MontrealQuebec, Canada
University of Saskatchewan, Clinical Trials Support UnitS7N 0W8, SaskatoonSaskatchewan, Canada

Sponsors and collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Lallemand Health Solutions

Collaborator