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Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients | Clinical Trials | Clareo Health

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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.

NCT06051123•Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

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.

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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:
+24 more criteria

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).
+15 more criteria

Locations (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Key Dates

Start Date

January 1, 2024

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2027

Last Updated

October 18, 2024

Enrollment

150

ESTIMATED participants

Conditions

ALSFTD

Interventions

Probiotic

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Contacts

Nora Robert, RN

CONTACT

514-890-8000 nora.robert.chum@ssss.gouv.qc.ca

Alice Cornet, B. SC

CONTACT

514-890-8000 alice.cornet.chum@ssss.gouv.qc.ca