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Intestinal Microbiome Transplant in ALS

NCT07017946 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-13

No results posted yet for this study

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 .

Conditions

  • Amyotrophic Lateral Sclerosis ALS

Interventions

DRUG

MTP-101C

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

Sponsors & Collaborators

Principal Investigators

  • Richard Bedlack, MD, PhD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2026-11-01
Completion
2026-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017946 on ClinicalTrials.gov