NCT07017946

Intestinal Microbiome Transplant in ALS

A Pilot Trial to Investigate the Safety and Efficacy of Intestinal Microbiome Transplant (MTT) in People With Amyotrophic Lateral Sclerosis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

This is a 24-week Phase I/II study of MTT in people with Amyotrophic Lateral Sclerosis. All participants will be evaluated clinically in person at weeks 0, 4, 12, and 24 visits. Blood and mailed/ fresh stool samples will be collected at weeks 0, 4, 8, 12, and 24. Blood samples will be used to determine changes in neurofilament light chain over time. Stool samples from weeks 0, 4,8, 12, and 24 will be processed by molecular methods (metagenomics and metatranscriptomics) for microbiome analysis. Participants will also have phone visits at weeks 1, 8, 16, and 20, which will be used to further evaluate safety and tolerability and the ALSFRS-R score. Participants will first undergo antibiotic conditioning with oral vancomycin 250 mg twice daily for 10 days. Neomycin 500 mg twice daily will be added to the last 3 days of vancomycin. This will be followed by ingestion of a standard bowel preparation with magnesium citrate. Participants will then ingest 2 capsules of MTP-101C daily for 3 days, then 1 capsule of MTP-101C daily for 8 weeks. All participants will be assigned to the investigational product.

Conditions

• Amyotrophic Lateral Sclerosis ALS

Interventions

Type	Name	Description
DRUG	MTP-101C	MTP-101C is a freeze-dried encapsulated formulation of fecal microbiota purified from the stool of healthy donors.

Timeline

• Start date: 2026-01-27
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-06-12
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study