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.
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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

Richard Bedlack, MD, PhD

919-613-2681

ALSresearch@duke.edu

CONTACT

Michelle Ward, RN

919-613-2681

ALSresearch@duke.edu

CONTACT