Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06051123

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

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-04-30

150

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

L

Lallemand Health Solutions

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 years or older
  • Diagnosis of ALS by El Escorial Criteria (possible, probable, probable with lab support, or definite)
  • Onset of weakness or speech impairment within 24 months before randomization
  • ALS Functional Rating Scale-Revised score of 24 or higher at screening, with no more than one subscore below 2
  • Slow Vital Capacity at screening of 60% or more predicted for sex, age, and height
  • Presence of frontotemporal dementia symptoms not required; participants with or without these symptoms are eligible
  • Has an informant or caregiver who frequently interacts and can provide accurate cognitive and behavioral information
  • Able to understand and sign informed consent
  • Childbearing potential participants must have a negative pregnancy test and agree to use approved birth control methods during the study, with hormonal methods used for at least 3 months
  • Willingness to maintain current eating habits
  • Willingness to avoid consuming probiotic supplements or foods with added probiotics or prebiotics throughout the study
  • Healthy controls aged 18 or older who can understand and sign informed consent
  • Healthy controls meeting birth control and eating habits criteria similar to ALS-FTDSD participants
  • Informants or caregivers aged 18 or older with frequent contact and ability to provide accurate cognitive information and willing to sign consent
Not Eligible

You will not qualify if you...

  • Use of respiratory support such as non-invasive or mechanical ventilation at screening
  • Medical or behavioral conditions that could interfere with trial participation as judged by the principal investigator
  • Use of feeding tube at randomization
  • Use of lipid-lowering drugs for less than 3 months before randomization
  • Starting lipid-lowering drugs during the trial unless due to acute coronary syndrome or stroke
  • Use of edaravone with stable dosage for less than 2 months before randomization
  • Use of riluzole with stable dosage for less than 1 month before randomization
  • Starting edaravone or riluzole during the trial
  • Immunodeficiency conditions including AIDS, lymphoma, long-term corticosteroid treatment, chemotherapy, or organ transplant
  • Pregnancy, planning pregnancy, or breastfeeding
  • Use of probiotics other than study medication in the month before randomization (eligible after 4-week washout)
  • Use of any antibiotic drug in the month before randomization (eligible after 4-week washout)
  • Allergy to milk or soy, or severe lactose intolerance
  • Current enrollment in another clinical trial
  • For healthy controls, similar exclusions including recent probiotic or antibiotic use, pregnancy, allergies, and clinical trial participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X 0A9

Actively Recruiting

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Research Team

A

Amélie Bujold, RN

CONTACT

R

Richard Miallot, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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