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Intestinal Microbiome Transplant in ALS
Sponsor: Duke University
Summary
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 .
Official title: A Pilot Trial to Investigate the Safety and Efficacy of Intestinal Microbiome Transplant (MTT) in People With Amyotrophic Lateral Sclerosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-01-27
Completion Date
2026-11-01
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
MTP-101C
MTP-101C is a freeze-dried encapsulated formulation of fecal microbiota purified from the stool of healthy donors.
Locations (1)
Duke University Medical Center
Durham, North Carolina, United States