Actively Recruiting
Intestinal Microbiome Transplant in ALS
Led by Duke University · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. Blood and mailed/ fresh stool samples will also be collected. Blood samples will be used to determine changes in neurofilament light chain over time. Stool samples will be processed for microbiome analysis. Participants will have phone visits to further evaluate safety and tolerability. They will then undergo antibiotic conditioning and a standard bowel preparation before being assigned to the investigational product, MTP-101C .
CONDITIONS
Official Title
Intestinal Microbiome Transplant in ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ALS according to Gold Coast Criteria
- Age 18 years or older at enrollment
- Fast-progressing ALS (ALSFRS-R decline of at least 1.5 points per month at screening)
- ALSFRS-R score of 24 or higher at screening
- Able to swallow capsules (ALSFRS-R swallowing score of 3 or 4)
- Expected to survive for the duration of the trial
- Stable use of riluzole, edaravone, and/or tofersen for 30 days prior or not using any during study
- Capable of giving written consent
- If sexually active, agree to use contraception or abstinence during treatment
- Females of child-bearing age must have a negative pregnancy test at screening
You will not qualify if you...
- Illness or lab abnormalities that could affect ALS progression measurement or study participation
- Use of probiotics, nutraceuticals, or herbal remedies within 2 weeks prior to screening
- Antibiotic use within 3 months prior to screening
- Use of investigational drugs within 30 days or five half-lives prior to screening
- Previous exposure to microbiome transplant therapy
- Pregnancy
- Known food allergy causing anaphylaxis
- Other co-morbid conditions increasing risk or interfering with study participation or objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27705
Actively Recruiting
Research Team
R
Richard Bedlack, MD, PhD
CONTACT
M
Michelle Ward, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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