NCT07017946RecruitingPhase 1/2
Intestinal Microbiome Transplant in ALS
A Pilot Trial to Investigate the Safety and Efficacy of Intestinal Microbiome Transplant (MTT) in People With Amyotrophic Lateral Sclerosis
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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 .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 4 Jun 2025
- Start date
- 27 Jan 2026
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Duke University
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07017946
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 27 Jan 2026 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.
- Previous exposure to MTT.
Other illness
- 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.
Lab values
- 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.
Other
- Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening
- Taking antibiotics within 3 months of screening.
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.