Phase 2 Motor Neurone Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with ALS (also known as motor neurone disease) using a specific set of diagnostic standards called the Gold Coast Criteria
• People who are 18 years of age or older at the time of joining
• People whose ALS is progressing quickly, based on scores from a standard ALS rating scale showing a decline of at least 1.5 points per month across the last two measurements before screening
• People who are moderately affected by ALS but not severely — specifically, those with a score of 24 or higher on the ALS rating scale at screening
• People who are able to swallow capsules and are expected to remain able to do so throughout the trial, based on their swallowing score on the ALS rating scale
• People who are expected to survive for the full duration of the trial
• People who are either taking riluzole, edaravone, and/or tofersen at a stable dose for at least 30 days before screening, or who are not taking any of these medicines and are not expected to start during the study
• People who are able to provide written consent to participate
• People who are sexually active and agree to use contraception or abstinence for the duration of the treatment period
• Women of childbearing potential who have a negative pregnancy test at the time of screening

Who may not be able to join:

• People with other illnesses or abnormal laboratory results that could interfere with measuring ALS progression, affect gut microbiome measurements, or make it difficult to complete the study
• People who have taken probiotics, nutritional supplements, or herbal remedies within 2 weeks before screening
• People who have taken antibiotics within 3 months before screening
• People who have taken any experimental drug as part of another study within 30 days before screening, or within five half-lives of that drug (whichever is longer) (confirm with trial site)
• People who have previously received a treatment called MTT (microbiota transfer therapy)
• People who are currently pregnant
• People with a known severe food allergy that has previously caused anaphylaxis (a life-threatening allergic reaction)
• People with other health conditions that, in the opinion of the trial investigator, could increase health risks, affect participation or compliance, or interfere with the trial's goals

Important: Always verify eligibility with the trial site directly before applying.