Actively Recruiting
Effects of Probiotics on Lipidomic Profile and Disease Evolution in ALS-FTDSD Patients: A Randomized Multicenter, Double-blind, Placebo-controlled Trial
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-04-30
150
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effects of a probiotic formulation on people with Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD). The study aims to understand how probiotics might change lipid profiles in participants compared to a placebo over time. This randomized, double-blind, parallel, placebo-controlled trial includes both ALS-FTDSD patients and healthy individuals for comparison. Participants will be randomly assigned to receive either a probiotic or a placebo, taking one sachet daily for 24 weeks. The study lasts 32 weeks in total, including the intervention and follow-up. ALS-FTDSD patients will have nine visits during the intervention—five in-person and four phone calls—and one follow-up call after. Healthy participants will have four in-person visits. During visits, participants complete questionnaires and provide blood and stool samples. Throughout the study, researchers will assess changes in lipid and metabolite composition in the blood as the primary outcome after 24 weeks. Secondary measures include various scores related to ALS function, cognitive abilities, neurofilament light chain concentration, and gut microbiota changes. Safety and adherence will be monitored, with the study concluding with a follow-up call. The total participation time is about eight months.
CONDITIONS
Brief Title
Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients
Who Can Participate
Eligibility Criteria
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 (ALSFRS-R) score 24 or higher at screening, with no more than one subscore below 2
- Forced vital capacity (SVC) at least 60% predicted for sex, age, and height at screening
- Presence of frontotemporal dementia symptoms not required; ALS diagnosis with or without FTD symptoms is eligible
- Having an informant or caregiver with frequent contact to provide accurate cognitive and behavioral information
- Ability to understand and sign informed consent
- Participants of child-bearing potential must have a negative pregnancy test and agree to use medically approved birth control during the study
- Willingness to maintain eating habits throughout the study
- Willingness to avoid probiotic supplements and foods with added probiotics or prebiotics from screening until study end
- Healthy controls aged 18 or older, able to consent, with similar birth control and dietary restrictions
- Informants or caregivers aged 18 or older with frequent contact and ability to consent
You will not qualify if you...
- Use of respiratory support (non-invasive ventilation or mechanical) at screening
- Significant medical or behavioral conditions interfering with trial participation
- Use of feeding tube at randomization
- Use of lipid-lowering drugs for less than 3 months before randomization
- Introduction of lipid-lowering drugs unless due to acute coronary syndrome or stroke
- Use of edaravone or riluzole with stable dosage for less than required periods before randomization
- Introduction of edaravone or riluzole during the trial
- Immunodeficiency or immune suppression (e.g., AIDS, lymphoma, long-term corticosteroids, chemotherapy, allograft)
- Pregnancy, planning pregnancy, or breastfeeding
- Use of probiotics or antibiotics within one month before randomization (unless after 4-week washout period)
- Milk and soy allergy or severe lactose intolerance
- Current enrollment in another clinical trial
- For healthy controls, similar restrictions on lipid-lowering drugs, pregnancy, probiotics, antibiotics, allergies, and trial enrollment apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take either a probiotic or placebo sachet daily for 24 weeks while attending scheduled visits for assessments.
For ALS-FTDSD participants, 9 visits during the intervention (5 in-person and 4 phone calls); for healthy participants, 4 in-person visits
Duration - Up to 1 week post-intervention
Participants have a follow-up call after completing the intervention to assess outcomes.
1 follow-up phone call
Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
Research Team
A
Amélie Bujold, RN
R
Richard Miallot, PhD
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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