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Probiotics for ALS (PROBIOTIC Trial)

N/A
Recruiting
Led By Genevieve Matte, MDCM, FRCP
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years old or greater.
Diagnosis of ALS by El Escorial Criteria revised (possible, probable, probable with lab support and definite).
Must not have
Use of respiratory support (non-invasive ventilation or mechanical respiratory support) at screening.
Immunodeficiency (immune-compromised and immune-suppressed participants, e.g., AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks

Summary

This trial will test if taking probiotics can improve the lipid profiles of people with ALS-FTDSD.

Who is the study for?
Adults diagnosed with ALS, regardless of FTD symptoms, who meet specific criteria like a certain level of physical function and willingness to maintain dietary habits. They must not have used probiotics recently and agree to avoid them during the trial. Women of childbearing age need a negative pregnancy test and must use birth control.
What is being tested?
The study is testing whether taking a probiotic formulation changes lipid profiles in ALS-FTDSD patients compared to those taking a placebo. The hypothesis suggests that the probiotics group will show different results over time.
What are the potential side effects?
While not explicitly stated, common side effects from probiotics may include digestive discomfort such as gas or bloating, allergic reactions for those sensitive to ingredients, or possible infections in very rare cases among immunocompromised individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with ALS according to specific criteria.
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My lung function test scores are normal for my age, sex, and height.
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I am using a form of hormonal birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use a machine to help me breathe.
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I have a weakened immune system due to a condition like AIDS or treatments like chemotherapy.
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I will start taking edaravone, riluzole, or ALBRIOZA™ during the trial.
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I am using a feeding tube.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in lipidomic profiles
Change in polar metabolite profiles
Secondary study objectives
Change in ALS-CBS score
Change in ALSAQ-5 scores
Change in ALSFRS-R score
+6 more
Other study objectives
Changes in lab safety marker: Complete Blood Count (CBC)
Changes in lab safety marker: creatinine
Changes in lab safety markers: Liver Function Test (LFT) - ALT
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental GroupExperimental Treatment1 Intervention
Participants in this group will be randomized to receive a probiotic formulation for 24 weeks.
Group II: Control GroupPlacebo Group1 Intervention
Participants in this group will be randomized to receive a placebo for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

Lallemand Health SolutionsIndustry Sponsor
41 Previous Clinical Trials
3,826 Total Patients Enrolled
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,370 Total Patients Enrolled
Genevieve Matte, MDCM, FRCPPrincipal InvestigatorCRCHUM
~100 spots leftby Feb 2027
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