Intestinal Microbiome Transplant in ALS
ConditionAmyotrophic Lateral Sclerosis ALS
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
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 .
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MTP-101C
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Duke University
Lead sponsor
University of Minnesota
Collaborator
Source ClinicalTrials.gov