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RECRUITING
NCT07017946
PHASE1/PHASE2

Intestinal Microbiome Transplant in ALS

Sponsor: Duke University

View on ClinicalTrials.gov

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

Interventions

DRUG

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