NCT07017946 · Duke University
Intestinal Microbiome Transplant in ALS
What this study 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.
View original scientific description
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 .
Interventions
DRUG
MTP-101C
MTP-101C is a freeze-dried encapsulated formulation of fecal microbiota purified from the stool of healthy donors.
Primary outcome measures
ALS Functional Rating Scale, Revised (ALSFRS-R)
Time frame: Weeks 0, 4, 8, 12, 16, 20 and 24
The ALSFRS-R is a quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. The total score ranges from 0 to 48, where higher scores indicate better function.
ALS Quality of Life (ALSAQ-5)
Time frame: Weeks 0, 4, 12, and 24
The overall ALSAQ-5 score ranges from 0 (best imaginable health state) to 100 (worst imaginable health state).
Neurofilament Light Chain levels
Time frame: Weeks 0, 4, 12 and 24
Neurofilament light chain levels are elevated in the spinal fluid and the blood of patients with ALS and other neurodegenerative diseases, and higher levels predict more severe disease progression.
The Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Weeks 0, 4, 12, and 24
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire that can be used weekly to assess the severity of gastrointestinal symptoms experienced over the past week. The GSRS is designed to evaluate symptoms associated with common gastrointestinal disorders, such as reflux, abdominal pain, indigestion, diarrhea, and constipation. The questionnaire uses a seven-point Likert-type scale, with 1 representing no symptoms and 7 representing very troublesome symptoms. Higher scores on the subscales indicate more discomfort.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of ALS according to Gold Coast Criteria
- Age: 18+ years at enrollment
- Fast-progressing (ALSFRS-R change of at least 1.5 points per month between last 2 measurements at screening)
- Modestly but not severely affected (ALSFRS-R score at or above 24 at screening)
- Able to swallow capsules and expected to be able to for the duration of the trial (ALSFRS-R "swallowing" score of 3 or 4 at screening)
- Expected to survive for the duration of the trial
- Taking any combination of riluzole, edaravone, and/or tofersen at a stable dose for 30 days prior to screening, or not taking any of these and not expected to during the study.
- Capable of giving written consent.
- If sexually active, must agree to use contraceptive or abstinence for duration of treatment.
- Females of child-bearing age must have negative pregnancy test at screening.
Exclusion criteria
- Concurrent illness or laboratory abnormalities that could confound the measurement of ALS progression or the microbiome or interfere with the ability to complete the study.
- Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening
- Taking antibiotics within 3 months of screening.
- Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.
- Previous exposure to MTT.
- Known specific food allergy with anaphylaxis
- Other co-morbid conditions that, in the opinion of the study investigator, place the participant at increased risk of complications, interfere with study participation or compliance, or confound study objectives.
Where
- Durham, North Carolina
Collaborators
University of Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations