Recruiting

Phase 1

Phase 2

MTP-101CIntestinal Microbiome Transplant in ALS

Sponsor:

Duke University

Code:

NCT07017946

Conditions

Amyotrophic Lateral Sclerosis ALS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MTP-101C

Study Details

Brief 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

Study ID

NCT07017946

Start date

Jan 27, 2026

Status verified date

Jul, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Diagnosis of ALS according to Gold Coast Criteria
Age: 18+ years at enrollment
Fast-progressing (ALSFRS-R change of at least 1.5 points per month between last 2 measurements at screening)
Modestly but not severely affected (ALSFRS-R score at or above 24 at screening)
Able to swallow capsules and expected to be able to for the duration of the trial (ALSFRS-R "swallowing" score of 3 or 4 at screening)
Expected to survive for the duration of the trial
Taking any combination of riluzole, edaravone, and/or tofersen at a stable dose for 30 days prior to screening, or not taking any of these and not expected to during the study.
Capable of giving written consent.
If sexually active, must agree to use contraceptive or abstinence for duration of treatment.
Females of child-bearing age must have negative pregnancy test at screening.

Exclusion Criteria:

Concurrent illness or laboratory abnormalities that could confound the measurement of ALS progression or the microbiome or interfere with the ability to complete the study.
Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening
Taking antibiotics within 3 months of screening.
Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.
Previous exposure to MTT.
Pregnancy.
Known specific food allergy with anaphylaxis
Other co-morbid conditions that, in the opinion of the study investigator, place the participant at increased risk of complications, interfere with study participation or compliance, or confound study objectives.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

MTP-101C

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

Primary outcome measure

ALS Functional Rating Scale, Revised (ALSFRS-R) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20 and 24 ]
ALS Quality of Life (ALSAQ-5) [ Time Frame: Weeks 0, 4, 12, and 24 ]
Neurofilament Light Chain levels [ Time Frame: Weeks 0, 4, 12 and 24 ]
The Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Weeks 0, 4, 12, and 24 ]

Central Contacts and Locations

Central contacts

Richard Bedlack, MD, PhD

919-613-2681 ALSresearch@duke.edu

Michelle Ward, RN

919-613-2681 ALSresearch@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Richard Bedlack, MD. PhD

919-613-2681

ALSresearch@duke.edu

Principal Investigator:

Richard Bedlack, MD, PhD

More Information

Sponsor

Duke University

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-07-08.