Intestinal Microbiome Transplant in ALS

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07017946
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Amyotrophic Lateral Sclerosis ALS

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 .

Key Dates

Start date
Jan 27, 2026
Status verified
Jun 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MTP-101C administration
    MTP-101C is a freeze-dried encapsulated universal donor microbiome-based formulation. Participants will ingest 2 capsules daily for 3 days then 1 capsule daily. This is preceded by antibiotic conditioning with a combination of vancomycin and neomycin, followed by a bowel purgative with magnesium citrate depending upon underlying comorbidities.

Primary Outcome Measure

ALS Functional Rating Scale, Revised (ALSFRS-R) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20 and 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27705
Richard Bedlack, MD. PhD
919-613-2681
[email protected]
Richard Bedlack, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

Related Studies