Probiotics for ALS

(PROBIOTIC Trial)

Overseen By Alice Cornet, B. SC

Age: 18+

Sex: Any

Trial Phase: Academic

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

Must not be taking: Antibiotics, Probiotics, Edaravone, others

Disqualifiers: Respiratory support, Immunodeficiency, Pregnancy, others

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must have stable dosages of certain ALS medications like edaravone, riluzole, or ALBRIOZA™ before joining. If you're taking probiotics or antibiotics, you need a 4-week break from them before starting the trial.

What data supports the effectiveness of the treatment Probiotics for ALS?

Research suggests that altering the gut microbiome, such as through probiotics, may help manage ALS by improving immune function and reducing inflammation. Studies have shown that ALS patients have different gut bacteria compared to healthy individuals, and probiotics could potentially restore a healthier balance. ^{1 2 3 4 5}

Is it safe for humans to take probiotics?

The research does not provide specific safety data for probiotics in humans, but probiotics are generally considered safe for most people. However, it's important to consult with a healthcare provider before starting any new supplement, especially for individuals with underlying health conditions. ^{1 2 3 4 6}

How does the probiotic treatment for ALS differ from other treatments?

The probiotic treatment for ALS is unique because it focuses on altering the gut microbiota (the community of microorganisms in the intestines) to potentially influence the immune system and slow disease progression, unlike traditional treatments that primarily target symptoms or extend life span by a few months. ^{1 2 4 7 8}

Research Team

Genevieve Matte, MDCM, FRCP

Principal Investigator

CRCHUM

Eligibility Criteria

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.

Inclusion Criteria

You must use two forms of contraception at the same time to prevent pregnancy.

We are looking for people who are generally healthy and don't have any specific medical conditions.

My weakness or speech problems started less than 2 years ago.

Exclusion Criteria

I use a machine to help me breathe.

I have been taking edaravone for less than 2 months.

I have been on a stable dose of riluzole or ALBRIOZA™ for less than a month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a probiotic formulation or placebo for 24 weeks

24 weeks

5 visits (in-person), 4 visits (phone calls)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up call

Treatment Details

Interventions

• Placebo
• Probiotic

Trial Overview 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.

Participant Groups

Group I: Experimental Group Experimental Treatment 1 Intervention

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

Group II: Control Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Lallemand Health Solutions

Industry Sponsor

Trials

44

Recruited

4,100+

Founded

1934

Headquarters

Mirabel, Canada

Known For

Microbiome therapies

Top Products

Lacidofil, ProbioKid, Probio'Stick, IBacilluS+

Findings from Research

This study will investigate the effects of Fecal Microbial Transplantation (FMT) on 42 early-stage ALS patients, aiming to increase the number and function of T regulatory lymphocytes (Tregs) to potentially shift the immune response to a more protective state against ALS progression.

The trial is unique as it is the first to explore FMT as a therapeutic intervention for ALS, with a focus on immunological changes and overall patient outcomes over a 12-month period, including safety and quality of life assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FETR-ALS Study Protocol: A Randomized Clinical Trial of Fecal Microbiota Transplantation in Amyotrophic Lateral Sclerosis. Mandrioli, J., Amedei, A., Cammarota, G., et al.[2020]

The gut microbiota of ALS patients shows significant differences compared to matched controls, indicating that microbiota composition may change as the disease progresses, with a notable decrease in microbial diversity over time.

While a 6-month probiotic treatment altered the gut microbiota composition in ALS patients, it did not restore biodiversity to levels seen in healthy controls nor did it impact disease progression as measured by ALSFRS-R.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective longitudinal study on the microbiota composition in amyotrophic lateral sclerosis. Di Gioia, D., Bozzi Cionci, N., Baffoni, L., et al.[2021]

In a study of 26 ALS patients, 65.4% showed signs of Glutamate Metabolism Dysfunction (GMD) after consuming a protein shake, indicating a potential issue with how their bodies process dietary glutamate compared to 30% of unaffected family members.

During a six-month treatment phase, patients with stable or improving GMD status experienced a slower decline in ALS symptoms, suggesting that addressing GMD could be a promising therapeutic target for ALS management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theme 6 Tissue biomarkers. Garnaas, KR., Kittelsrud, J., Behnke, M.[2020]

In a one-year double-blind trial involving 22 patients with amyotrophic lateral sclerosis (ALS), those treated with branched-chain amino acids (12 g L-leucine, 8 g L-isoleucine, and 6.4 g L-valine) maintained muscle strength and walking ability, unlike the placebo group which experienced a decline.

The results suggest that branched-chain amino acids may provide a therapeutic benefit in preserving muscle function in ALS patients, highlighting their potential role in managing this progressive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of branched-chain aminoacids in amyotrophic lateral sclerosis. Plaitakis, A., Smith, J., Mandeli, J., et al.[2019]

ALS patients show a distinct gut microbiome composition, characterized by increased diversity and a deficiency in Prevotella spp., compared to their spouses, indicating potential microbiome-related factors in the disease.

The study suggests that targeting the gut microbiome, particularly by addressing the deficiency in Prevotella spp. and enhancing butyrate metabolism, could offer new avenues for ALS treatment, as these metabolic pathways were found to be less active in ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut microbiome differences between amyotrophic lateral sclerosis patients and spouse controls. Hertzberg, VS., Singh, H., Fournier, CN., et al.[2023]

In a double-blind, placebo-controlled trial involving 126 ALS patients, branched-chain amino acids (BCAA) showed no efficacy in improving disability scales compared to placebo.

The trial was halted due to an observed excess mortality in the BCAA treatment group, raising safety concerns about the use of BCAA in ALS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Branched-chain amino acids and amyotrophic lateral sclerosis: a treatment failure? The Italian ALS Study Group. [2019]

A case study of a female ALS patient showed that washed microbiota transplantation (WMT) led to significant improvements in her condition over a 12-month follow-up, suggesting a potential new treatment for ALS.

The patient's disease progression was halted after WMT, even after a setback caused by antibiotics, indicating that WMT may help manage ALS symptoms and possibly improve quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Washed microbiota transplantation stopped the deterioration of amyotrophic lateral sclerosis: The first case report and narrative review. Lu, G., Wen, Q., Cui, B., et al.[2023]

In a study using G93A transgenic mice, which model human ALS, treatment with butyrate improved gut health and extended lifespan, suggesting that gut microbiome dysfunction may contribute to ALS progression.

Butyrate treatment also reduced the aggregation of a mutated protein associated with ALS, indicating its potential as a therapeutic agent for restoring gut microbiome balance and alleviating disease symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Target Intestinal Microbiota to Alleviate Disease Progression in Amyotrophic Lateral Sclerosis. Zhang, YG., Wu, S., Yi, J., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

FETR-ALS Study Protocol: A Randomized Clinical Trial of Fecal Microbiota Transplantation in Amyotrophic Lateral Sclerosis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A prospective longitudinal study on the microbiota composition in amyotrophic lateral sclerosis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Theme 6 Tissue biomarkers. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Pilot trial of branched-chain aminoacids in amyotrophic lateral sclerosis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Gut microbiome differences between amyotrophic lateral sclerosis patients and spouse controls. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Branched-chain amino acids and amyotrophic lateral sclerosis: a treatment failure? The Italian ALS Study Group. [2019]

7. China pubmed.ncbi.nlm.nih.gov

Washed microbiota transplantation stopped the deterioration of amyotrophic lateral sclerosis: The first case report and narrative review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Target Intestinal Microbiota to Alleviate Disease Progression in Amyotrophic Lateral Sclerosis. [2019]