Intestinal Microbiome Transplant for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called MTP-101C for individuals with ALS, a disease affecting nerve cells in the brain and spinal cord, leading to muscle control issues. The researchers aim to determine if altering gut bacteria can impact the disease, using a capsule-based treatment (intestinal microbiome transplant) following antibiotics and a bowel cleanse. Participants will attend in-person and phone check-ins to monitor their safety and any symptom changes. Individuals with fast-progressing ALS who can still swallow capsules may be suitable for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking ALS research.
Will I have to stop taking my current medications?
The trial requires that if you are taking riluzole, edaravone, or tofersen, you must be on a stable dose for 30 days before the trial and continue it during the study. You cannot take probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening, or antibiotics within 3 months of screening.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that fecal microbiota transplantation (FMT) is generally safe for people with ALS. One study found that FMT was well-tolerated and helped slow the loss of function in some patients. Another study involving 27 ALS patients reported no major side effects from FMT, although it did not significantly slow the disease's progression based on certain measures. Overall, these findings suggest that the treatment is relatively safe and may offer some benefits.12345
Why do researchers think this study treatment might be promising for ALS?
Unlike the standard treatments for ALS, which mainly focus on managing symptoms with medications like riluzole and edaravone, MTP-101C takes a completely different approach by targeting the gut microbiome. Researchers are excited about MTP-101C because it uses a freeze-dried encapsulated universal donor microbiome-based formulation, which could potentially modify disease progression by influencing the body's immune and inflammatory responses. This novel treatment is administered orally through capsules, making it a non-invasive option. By altering the intestinal microbiome, MTP-101C offers a unique mechanism that could complement or enhance the effects of existing therapies.
What evidence suggests that this treatment might be an effective treatment for ALS?
Research has shown that fecal microbiota transplantation (FMT) can restore the balance of gut bacteria, potentially improving conditions like ALS. Studies have found that FMT greatly enhances gut health by introducing beneficial bacteria. For ALS, a disease affecting the nerves, a healthier gut may help manage symptoms or slow disease progression. Early findings suggest FMT might alter disease development, but more research is needed to confirm these effects specifically for ALS. In this trial, participants will receive MTP-101C, a freeze-dried encapsulated universal donor microbiome-based formulation, to promote a healthier internal environment. The treatment transfers healthy bacteria from a donor to the patient's gut.15678
Who Is on the Research Team?
Richard Bedlack, MD, PhD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for people with ALS who can attend four in-person visits and provide blood and stool samples. They must be able to undergo antibiotic conditioning and bowel preparation before receiving the investigational product, MTP-101C.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Antibiotic Conditioning
Participants undergo antibiotic conditioning with oral vancomycin and neomycin followed by a bowel preparation
Treatment
Participants ingest MTP-101C capsules daily following antibiotic conditioning
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MTP-101C
Trial Overview
The study tests an intestinal microbiome transplant called MTP-101C over a period of 24 weeks. Participants will have clinical evaluations, phone check-ins for safety, and provide samples to monitor changes in their neurofilament light chain and gut microbiome.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
MTP-101C is a freeze-dried encapsulated universal donor microbiome-based formulation. Participants will ingest 2 capsules daily for 3 days then 1 capsule daily. This is preceded by antibiotic conditioning with a combination of vancomycin and neomycin, followed by a bowel purgative with magnesium citrate depending upon underlying comorbidities.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
University of Minnesota
Collaborator
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07017946?term=intestinal%20microbiota%20transplantation&viewType=Table&rank=8NCT07017946 | Intestinal Microbiome Transplant in ALS
This is a 24-week Phase I/II study of MTT in people with Amyotrophic Lateral Sclerosis. All participants will be evaluated clinically in person at weeks 0, 4, ...
Effect of fecal microbiota transplantation on patients with ...
Fecal microbiota transplantation (FMT) has emerged as a promising method for restoring intestinal microbial ecology [19], widely recognized for ...
Fecal microbiota transplantation significantly improved ...
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that leads to respiratory failure, and eventually death.
Intestinal Microbiome Transplant for ALS · Info for Participants
This is a 24-week study of intestinal microbiome transplant in people with ALS. All participants will be evaluated clinically in person for 4 visits.
NCT03766321 | Fecal Microbiota Transplantation Effect on ...
This interventional study aims at evaluating the biological and disease-modifying effects of Fecal Microbiota Transplant (FMT) in patients affected by ...
Fecal Microbiota Transplantation Effect on Amyotrophic ...
This interventional study aims at evaluating the biological and disease-modifying effects of Fecal Microbiota Transplant (FMT) in patients affected by ...
IDDF2024-ABS-0384 Efficacy and safety of fecal ...
FMT showed efficacy and safety for ALS with slower functional decline. FMT might improve bulbar and respiratory function and ameliorate life quality.
Effect of fecal microbiota transplantation on patients with ...
In this clinical trial involving 27 sporadic ALS patients, FMT did not significantly slow the decline in ALSFRS-R score.
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