Intestinal Microbiome Transplant in ALS
Recruiting
Phase 1
Phase 2
Interventional Study
Amyotrophic Lateral Sclerosis ALS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Duke University · Other
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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 furt…
Trial Locations
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Eligibility 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)
* A…
Contacts