Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

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

Sponsors and collaborators