Intestinal Microbiome Transplant in ALS

Korábbi kezelés

• Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.
• Previous exposure to MTT.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening
• Taking antibiotics within 3 months of screening.
• Pregnancy.

• 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.