Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder … (NCT06051123) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients
Canada150 participantsStarted 2024-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. SVC greater than or equal to 60% predicted for sex, age and height at screening.
. Note on FTD Symptoms: The presence of FTD symptoms is not a requirement for inclusion in this study. Participants with a diagnosis of ALS, whether or not accompanied by FTD symptoms, are eligible for inclusion. No prior or screening diagnosis of FTDSD is required.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in lipids and polar metabolites composition in the plasma of participant
Timeframe: 24 weeks
Trial details
NCT IDNCT06051123
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
. Subject has an informant/caregiver who has frequent and sufficient contact to provide accurate information about the patient's cognitive abilities and behaviors to complete the ALS-CBS.
. Participants apt to comprehend and sign the ICF.
Exclusion criteria
. 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.
. Introduction of lipid-lowering drug unless it is due to the event of acute coronary syndrome or stroke as per Canadian guidelines.
. 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.
. Introduction of edaravone or riluzole during the clinical trial.