Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients

NCT06051123 | Recruiting

• 1 other identifier: 2024-11453
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 compared to participants receiving the placebo at different time points.

Conditions

ALSFTD; ALS (Amyotrophic Lateral Sclerosis); Frontal Temporal Dementia (FTD)

Keywords

ALS; FTD; motor function; probiotics; lipidomics; metabolites; neurofilament; microbiome

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (6)

• Change in ALS Functional Rating Scale Revised (ALSFRS-R) score

  24 weeks

• Change in ALS-CBS score

  24 weeks

• Change in neurofilament light chain concentration

  24 weeks

• Change in ALSAQ-5 scores

  24 weeks

• Change in fecal microbiota in ALS-FTDSD patients

  24 weeks

Other Outcomes (6)

• Number of AEs and SAEs

  28 weeks

• Changes in lab safety marker: Complete Blood Count (CBC)

  24 weeks

• Changes in lab safety markers: Liver Function Test (LFT) - ALT

  24 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in this group will be randomized to receive a probiotic formulation for 24 weeks.

Dietary Supplement: Probiotic

Control Group

PLACEBO COMPARATOR

Participants in this group will be randomized to receive a placebo for 24 weeks.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Participants will be taking 1 sachet a day.

Experimental Group

Placebo DIETARY_SUPPLEMENT

Participants will be taking 1 sachet a day.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

MeSH Terms

Conditions

Frontotemporal Dementia With Motor Neuron Disease; Amyotrophic Lateral Sclerosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Genevieve Matte, MDCM, FRCP

  CRCHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Bujold, RN

CONTACT

514-890-8000; amelie.bujold.chum@ssss.gouv.qc.ca

Richard Miallot, PhD

CONTACT

514-890-8000; richard.miallot.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 2 study

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: September 22, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)