ALSFTDPROBIOTICNCT06051123
Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients
A study testing Probiotic in people with ALSFTD and ALS (Amyotrophic Lateral Sclerosis), run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ALSFTD, ALS (Amyotrophic Lateral Sclerosis), Frontal Temporal Dementia (FTD)
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jan 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria to be eligible for enrolment 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 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.
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- 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 ICF.
- 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:
- 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
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- 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.
- 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:
- 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
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- 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
Who cannot join
- 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 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.
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- 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.
- Immunodeficiency (immune-compromised and immune-suppressed participants, e.g., AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants).
- Pregnancy (as per serum HCG pregnancy test at screening), planning to be pregnant or currently breastfeeding.
- 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 period.
- Use of any antibiotic drug in the month prior to randomization. Note: participants could be eligible to participate after a 4-week washout period.
- Milk and soy allergy, or severe lactose intolerance.
- Currently enrolled in another clinical trial.
- Healthy controls:
- 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.
- Pregnancy (as per serum HCG pregnancy test at screening), planning to be pregnant or currently breastfeeding. Note: participants will not take the IP or placebo, but pregnancy is a major factor that could affect lipidomic profiling.
- 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.
- 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.
- Currently enrolled in another clinical trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 0C7
Susan McCully, RN MN, (506) 471-9924, Susan.mccully@horizonnb.ca
Colleen O'Connell, MD, FRCPC
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Amélie Bujold, RN, 5148908000 ext. 13616, amelie.bujold.chum@ssss.gouv.qc.ca
Richard Miallot, PhD, 5148908000 ext. 13616, richard.miallot.chum@ssss.gouv.qc.ca
- Recruiting
University of Saskatchewan, Clinical Trials Support Unit
Saskatoon, Saskatchewan, S7N 0W8
Janet Peters, Clinical Research Coordinator, RN, +1 639 317 5899, janet.peters@usask.ca
Joanne Boyer, RN, +1 306 280 8001, joanne.boyer@usask.ca
About this study
Official title: Effects of Probiotics on Lipidomic Profile and Disease Evolution in ALS-FTDSD Patients: A Randomized Multicenter, Double-blind, Phase II, Placebo-controlled, Parallel 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.
Read the detailed description
Individuals with ALS-FTDSD, their caregivers and healthy individuals can participate in this randomized, double-blind, parallel, placebo-controlled study. Participants will be enrolled for a period of 32 weeks, with an intervention period of 24 weeks. For ALS-FTDSD participants, there will be 9 visits during the intervention (5 in-person and 4 phone calls) and 1 follow-up call post-intervention. For healthy participants, there will be 4 in-person visits. For all participants, in-person visits will involve filling out questionnaires, giving blood samples, and returning stool samples.
- Being tested
- Probiotic, Placebo
- Keywords
- ALS, FTD, motor function, probiotics, lipidomics, metabolites, neurofilament, microbiome
- Medical subject headings
- Frontotemporal Dementia With Motor Neuron Disease, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Participants will be taking 1 sachet a day.
PlaceboDietary supplement
Participants will be taking 1 sachet a day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this group will be randomized to receive a probiotic formulation for 24 weeks. Receives: Dietary Supplement: Probiotic |
| Control Group | Placebo comparator | Participants in this group will be randomized to receive a placebo for 24 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipids and polar metabolites composition in the plasma of participant
Metabolomics will provide a quantitative and qualitative assesment of the lipidomic and polar metabolite profiles of participants on the probiotic arm and the participants on the placebo arm. Participants will be assessed at week 0, at week 12 and then at the end of the investigation period at week 24.
Measured: 24 weeks
Secondary outcomes (6)
Change in ALS Functional Rating Scale Revised (ALSFRS-R) score
Participants' ALS Functional Rating Scale Revised (ALSFRS-R) score, following intake of the probiotic or placebo. Participants will be assessed at week 0, at week12 and then at the end of the investigation period at week 24.
Measured: 24 weeks
Change in ALS-CBS score
To compare the average change from baseline in ALS Cognitive Behavioral Screen (ALS-CBS) and Frontal Assessment Battery (FAB) between the probiotic and placebo groups over the 24 weeks of intervention.
Measured: 24 weeks
Change in neurofilament light chain concentration
To compare the average change from baseline in the neurofilament light chain concentration between the probiotic and placebo groups over the 24 weeks of intervention.
Measured: 24 weeks
Change in ALSAQ-5 scores
To compare the average change from baseline in the Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) between the probiotic and placebo groups over the 24 weeks of intervention.
Measured: 24 weeks
Change in fecal microbiota in ALS-FTDSD patients
To compare the fecal microbiota composition, diversity, and strain recovery over the 24 weeks of intervention in the probiotic and placebo groups. Techniques will be based on the extraction of DNA and amplification of 16S ribosomal RNA genes. These genes are highly conserved between bacterial species, but vary in a manner that allows species identification.
Measured: 24 weeks
Lipidomic profiles of healthy participants
To explore lipidomic profiles from baseline in healthy participants over the 24 weeks of intervention. This will be a lipid profiling and quantification by using mass-spectrometry-based lipidomics. We are going to test 900 different lipids, which can be classified in 20 classes ans subclasses of interest.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Jan 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSFTDStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2 study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Genevieve Matte, MDCM, FRCP, Principal investigator, CRCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051123
- Sponsor's protocol ID
- 2024-11453
- Acronym
- PROBIOTIC
- Status last verified
- Jun 2026
- First submitted
- 11 Aug 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics on Lipidomic Profile and Disease Evolution in ALS-FTDSD Patients: A Randomized Multicenter, Double-blind, Phase II, Placebo-controlled, Parallel Trial.
- ClinicalTrials.gov ID
- NCT06051123
- Acronym / sponsor ID
- PROBIOTIC / 2024-11453
- Keywords
- ALS, FTD, motor function, probiotics, lipidomics, metabolites, neurofilament, microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with ALS-FTDSD, their caregivers and healthy individuals can participate in this randomized, double-blind, parallel, placebo-controlled study. Participants will be enrolled for a period of 32 weeks, with an intervention period of 24 weeks. For ALS-FTDSD participants, there will be 9 visits during the intervention (5 in-person and 4 phone calls) and 1 follow-up call post-intervention. For healthy participants, there will be 4 in-person visits. For all participants, in-person visits will involve filling out questionnaires, giving blood samples, and returning stool samples.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 2 study
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: ProbioticParticipants in this group will be randomized to receive a probiotic formulation for 24 weeks. |
| Control Group | Placebo comparator | Dietary Supplement: PlaceboParticipants in this group will be randomized to receive a placebo for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Participants must meet all of the following inclusion criteria to be eligible for enrolment 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 randomization.
- ALSFRS-R equal or superior to 24/48 at screening, with no more than one subscore under 2/4.
Key exclusion criteria (24 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticParticipants will be taking 1 sachet a day. | Dietary supplement | Experimental Group |
| PlaceboParticipants will be taking 1 sachet a day. | Dietary supplement | Control Group |
Primary outcome
Change in lipids and polar metabolites composition in the plasma of participant
Time frame: 24 weeks
Metabolomics will provide a quantitative and qualitative assesment of the lipidomic and polar metabolite profiles of participants on the probiotic arm and the participants on the placebo arm. Participants will be assessed at week 0, at week 12 and then at the end of the investigation period at week 24.
6 secondary outcomes
Change in ALS Functional Rating Scale Revised (ALSFRS-R) score
Time frame: 24 weeks
Change in ALS-CBS score
Time frame: 24 weeks
Change in neurofilament light chain concentration
Time frame: 24 weeks
Change in ALSAQ-5 scores
Time frame: 24 weeks
Change in fecal microbiota in ALS-FTDSD patients
Time frame: 24 weeks
Lipidomic profiles of healthy participants
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Genevieve Matte, MDCM, FRCP principal investigator
CRCHUM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with ALSFTD and ALS (Amyotrophic Lateral Sclerosis), run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie Bujold, RN (514-890-8000 ext. 13616, amelie.bujold.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lipids and polar metabolites composition in the plasma of participant (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.