Intestinal microbiome transplant for people with ALS
Official title: A Pilot Trial to Investigate the Safety and Efficacy of Intestinal Microbiome Transplant (MTT) in People With Amyotrophic Lateral Sclerosis
Run by Duke University · NCT07017946 · Data updated 2026-11-12
This 24-week treatment tests whether taking MTP-101C capsules after antibiotic conditioning and bowel prep can change the gut microbiome and a blood marker in people with fast-progressing ALS who can swallow pills.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | January 27, 2026 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07017946 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with ALS by Gold Coast criteria who are fast-progressing (ALSFRS-R decline ≥1.5 points/month), have ALSFRS-R ≥24, can swallow capsules, and can attend scheduled in-person visits over 24 weeks.
✕Probably not a fit
People with slowly progressing or very advanced ALS (ALSFRS-R <24), those unable to swallow capsules, with major comorbidities that confound ALS measurement, or who cannot complete antibiotic conditioning or required visits are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants undergo antibiotic conditioning followed by a standard bowel preparation and then take MTP-101C capsules daily for several weeks. Clinical visits occur in person at weeks 0, 4, 12, and 24 with phone safety checks at intervening time points. Blood samples will be used to measure neurofilament light chain over time and stool samples will be analyzed by metagenomics and metatranscriptomics to profile microbiome changes. All participants receive the investigational product and safety and tolerability are closely monitored.
Why it matters
Potential benefit: If successful, this treatment could shift gut bacterial communities and lower neurofilament light chain levels, which might slow functional decline in ALS.
How similar studies have gone: Microbiome transplantation in ALS is relatively novel; small preclinical and early human reports suggest possible effects on disease biology but robust clinical benefit has not been proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. * Pregnancy. * 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 it's running
-
Duke University Medical Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Richard Bedlack, MD, PhD — Duke University
- Study coordinator: Richard Bedlack, MD, PhD
- Email: ALSresearch@duke.edu
- Phone: 919-613-2681
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.