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New treatment option for ALSFTD
Official title Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients
ClinicalTrials.gov ID: NCT06051123
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Participants must meet all of the following 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.
You likely can't join if
- people 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...
- 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.
See the full eligibility criteria
Who can join
- Participants must meet all of the following 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- people 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.
- 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...
- 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...
- 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...
- 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...
- Currently enrolled in another clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Fredericton, New Brunswick, Canada
- Montreal, Quebec, Canada
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fredericton, New Brunswick, Canada; Montreal, Quebec, Canada; Saskatoon, Saskatchewan, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.