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.
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 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.
Inclusion Criteria:
ALS participants:
1. Aged 18 years old or greater.
2. Diagnosis of ALS by El Escorial Criteria revised (possible, probable, probable with
lab support and definite).
3. Onset of weakness or speech impairment no more than 24 months before randomization.
4. 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).
5. SVC greater than or equal to 60% predicted for sex, age and height at screening.
6. 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.
7. 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.
8. Participants apt to comprehend and sign the ICF.
9. 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:
1. Abstinence or agrees to use contraception if planning to become sexually
active.
2. Hormonal contraceptives including oral contraceptives, hormone birth control
patch, vaginal contraceptive ring, injectable contraceptives, or hormone
implant
3. Double-barrier method
4. Intrauterine devices
5. Non-heterosexual lifestyle or agrees to use contraception if planning on
changing to heterosexual partner(s)
6. Vasectomy of partner at least 6 months prior to screening
10. Willing to maintain eating habits throughout the study.
11. 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:
1. Aged 18 years old or greater.
2. Able to comprehend and willing to sign ICF.
3. 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:
1. Abstinence or agrees to use contraception if planning to become sexually
active.
2. Hormonal contraceptives including oral contraceptives, hormone birth control
patch, vaginal contraceptive ring, injectable contraceptives, or hormone
implant
3. Double-barrier method
4. Intrauterine devices
5. Non-heterosexual lifestyle or agrees to use contraception if planning on
changing to heterosexual partner(s)
6. Vasectomy of partner at least 6 months prior to screening
4. Willing to maintain eating habits throughout the study.
5. 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:
1. Aged 18 years old or greater.
2. Has frequent and sufficient contact to provide accurate information about the
patient's cognitive abilities and behaviors to complete the ALS-CBS.
3. Able to comprehend and willing to sign ICF.
Exclusion Criteria:
ALS Participants:
1. Use of respiratory support (non-invasive ventilation or mechanical respiratory
support) at screening.
2. Significant medical condition or behavioral issues that could interfere with
participation in the clinical trial in the principal investigator's opinion.
3. Use of a feeding tube at randomization.
4. Use of lipid-lowering drugs for less than 3 months before randomization.
5. Introduction of lipid-lowering drug unless it is due to the event of acute coronary
syndrome or stroke as per Canadian guidelines.
6. Use of edaravone with stable dosage for less than 2 months before randomization.
7. Use of riluzole, or ALBRIOZA™ with stable dosage for less than 1 month before
randomization.
8. Introduction of edaravone, riluzole or ALBRIOZA™ during the clinical trial.
9. Immunodeficiency (immune-compromised and immune-suppressed participants, e.g., AIDS,
lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy
and allograft participants).
10. Pregnancy (as per serum HCG pregnancy test at screening), planning to be pregnant or
currently breastfeeding.
11. 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.
12. Use of any antibiotic drug in the month prior to randomization. Note: participants
could be eligible to participate after a 4-week washout period.
13. Milk and soy allergy, or severe lactose intolerance.
14. Currently enrolled in another clinical trial.
Healthy Participants:
1. Use of lipid-lowering drugs for less than 3 months before randomization.
2. Introduction of lipid-lowering drug unless it is due to the event of acute coronary
syndrome or stroke as per Canadian guidelines.
3. 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.
4. 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.
5. 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.
6. 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.
7. Currently enrolled in another clinical trial.