Testing Probiotic against a placebo for ALSFTD
Official title: Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients
Effects of Probiotics on Lipidomic Profile and Disease Evolution in ALS-FTDSD Patients: A Randomized Multicenter, Double-blind, Phase II, Placebo-controlled, Parallel Trial.
- 2 groups
- Sites in Fredericton, Montreal and 1 more city
- Recruiting
Interventions
- Other intervention
Probiotic
Participants will be taking 1 sachet a day.
- Other intervention
Placebo
Participants will be taking 1 sachet a day.
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
- Recruiting
University of Saskatchewan, Clinical Trials Support Unit
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for58 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants of child-bearing potential must have a negative serum pregnancy test at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → and agree to use a medically approved method of birth controlControl groupThe group a new treatment is measured against.Read more → for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- +Participants of child-bearing potential must have a negative serum pregnancy test at screening and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- +Participants must meet all of the following inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → to be eligible for enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → into the study:ALS-FTDSD participants
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +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.
- +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 ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Double-barrier method
- +Intrauterine devices
- +Vasectomy of partner at least 6 months prior to screening
- +Willing to maintain eating habits throughout the study.
- +Willing to refrain from consuming probiotic supplements and food containing added probiotics and/or prebiotics (e.g., yogurts with live, active cultures or supplements) from the moment of screening until the end of the study.
- +Healthy controls:
- +Aged 18 years old or greater.
- +Able to comprehend and willing to sign ICF.
- +Double-barrier method
- +Intrauterine devices
- +Vasectomy of partner at least 6 months prior to screening
- +Willing to maintain eating habits throughout the study.
- +Willing to refrain from consuming probiotic supplements and food containing added probiotics and/or prebiotics (e.g., yogurts with live, active cultures or supplements) from the moment of screening until the end of the study.
- +Informant/caregiver
- +Aged 18 years old or greater.
- +Has frequent and sufficient contact to provide accurate information about the patient's cognitive abilities and behaviors to complete the ALS-CBS.
- +Able to comprehend and willing to sign ICF
- +Abstinence or agrees to use contraception if planning to become sexually active.
- +Hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant
- +Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- +Abstinence or agrees to use contraception if planning to become sexually active.
- +Hormonal contraceptives including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant
- +Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
Exclusion
- −Milk and soy allergy, or severe lactose intolerance.
- −Milk and soy allergy, or severe lactose intolerance. Note: Although participants will not consume any study product, we aim to maintain environmental factors comparable to the ALS-FTDSD group. We aim to exclude allergies, so participants are maintained on standard diet.
- −Subjects with any of the following characteristics/conditions will not be included in the study:
- −ALS-FTDSD participants
- −Use of respiratory support (non-invasive ventilation or mechanical respiratory support) at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Significant medical condition or behavioral issues that could interfere with participation in the clinical trialInterventional studyA study where participants are given something to see what happens.Read more → in the principal investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion.
- −Use of a feeding tube at randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −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.
- −Use of probiotics other than the study medication in the month prior to randomization. Note: participants could be eligible to participate after a 4-week washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more →.
- −Use of any antibiotic drug in the month prior to randomization. Note: participants could be eligible to participate after a 4-week washout period.
- −Currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical trial.
- −Healthy controlsControl groupThe group a new treatment is measured against.Read more →:
- −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 probiotics in the month prior to day 0 of the study (visit 2). Note: participants could be eligible to participate after a 4-week washout period. Although participants will not consume any study product, we aim to maintain environmental factors comparable to the ALS-FTDSD group.
- −Use of any antibiotic drug in the month prior to day 0 of the study (visit 2). Note: participants could be eligible to participate after a 4-week washout period. Although participants will not consume any study product, we aim to maintain environmental factors comparable to the ALS-FTDSD group.
- −Currently enrolled in another clinical trial.
- −Pregnancy (as per serum HCG pregnancy test at screening), planning to be pregnant or currently breastfeeding.
- −Pregnancy (as per serum HCG pregnancy test at screening), planning to be pregnant or currently breastfeeding. Note: participants will not take the IP or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →, but pregnancy is a major factor that could affect lipidomic profiling.
- −Immunodeficiency (immune-compromised and immune-suppressed participants, e.g., AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Probiotic.
Registry label: A: Experimental Group
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Control Group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 150 people.
The study is currently expected to finish around February 2027.
The main measurement is taken over: 24 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in lipids and polar metabolites composition in the plasma of participant — measured over 24 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06051123 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ProbioticDietary supplement
Participants will be taking 1 sachet a day.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About PlaceboDietary supplement
Participants will be taking 1 sachet a day.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 24 weeks.
The study as a whole is currently expected to finish around 2027-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 150 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Fredericton, New Brunswick, Canada; Montreal, Quebec, Canada; Saskatoon, Saskatchewan, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.