← Back to Search

Other

Probiotics for ALS (PROBIO_HA114 Trial)

Phase 2

Waitlist Available

Led By Geneviève 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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 weeks

Awards & highlights

PROBIO_HA114 Trial 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.Check my eligibility

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.See study design

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.

PROBIO_HA114 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with ALS according to specific criteria.

Select...

My lung function test scores are normal for my age, sex, and height.

Select...

I am using a form of hormonal birth control.

PROBIO_HA114 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in lipidomic profiles

Change in polar metabolite profiles

Secondary outcome measures

Change in ALS-CBS score

Change in ALSAQ-5 scores

Change in ALSFRS-R score

+6 more

Other outcome measures

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

PROBIO_HA114 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lallemand Health SolutionsIndustry Sponsor

39 Previous Clinical Trials

3,569 Total Patients Enrolled

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,487 Total Patients Enrolled

Geneviève Matte, MDCM, FRCPPrincipal InvestigatorCRCHUM

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Experimental Group been given regulatory approval by the FDA?

"Our risk assessment determined that experimental group merits a score of 2, as the trial is in its second phase and has evidence to back up safety but not efficacy."

Answered by AI

Is this research currently in need of participants?

"Clinicaltrials.gov shows that recruitment for this intervention ceased on September 18th 2023 - shortly after the initial posting of October 1st 2024. However, presently there is at least one medical trial searching for participants."

Answered by AI

What is the main goal of this trial's research efforts?

"The primary objective of the evaluation period, which can span up to 24 weeks, is to gauge changes in polar metabolite profiles. Other metrics assessed include an alteration in ALS-CBS and FAB scores as well as neurofilament light chain concentration for both probiotic and placebo based groups."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Effects of Probiotics in Amyotrophic Lateral Sclerosis-Frontotemporal Dementia Spectrum Disorder (ALS-FTDSD) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06051123.

All > Semantic Dementia > Microbiome