Status:
RECRUITING
Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Lallemand Health Solutions
Conditions:
ALSFTD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 co...
Detailed Description
Individuals with ALS-FTDSD 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...
Eligibility Criteria
Inclusion
- ALS 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. ALSFRS-R slope of decline of at least 0.5 points per month on the ALSFRS- R, calculated as (48-score at screening)/ (months since onset of weakness).
- 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 ICF.
- Participants of child-bearing potential must have a negative urine 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 urine 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
- Informants/caregivers:
- 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.
Exclusion
- ALS 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.
- 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, or ALBRIOZA™ with stable dosage for less than 1 month before randomization.
- Introduction of edaravone, riluzole or ALBRIOZA™ 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 Participants:
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06051123
Start Date
January 1 2024
End Date
February 1 2027
Last Update
October 18 2024
Active Locations (1)
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1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0A9