A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis

This single-center, open-label pilot study will enroll approximately 15 adults with amyotrophic lateral sclerosis (ALS) to assess the safety and tolerability of adding Alsum30 to their care. Alsum30 consists of a broccoli seed extract tablet containing glucoraphanin, a precursor of sulforaphane, and a probiotic powder containing Bacillus coagulans GBI-30, 6086 (BC30). All participants will receive Alsum30; there is no placebo or comparison group. Participants will complete a six-week pretreatment observation period, take Alsum30 for 24 weeks, and have a safety follow-up after treatment. Researchers will record adverse events, safety laboratory results, and early treatment discontinuations. They will also explore changes in ALS function, breathing, quality of life, cognition, and the blood biomarkers. The findings will help plan future controlled studies.

Inclusion Criteria Participants may be enrolled if they meet all of the following criteria: 1\. Aged 18 to 75 years, inclusive, of any sex. 2. Diagnosis of amyotrophic lateral sclerosis confirmed by a neurologist experienced in the diagnosis and management of ALS, according to either of the following diagnostic pathways: 1. The Gold Coast diagnostic criteria for ALS; or 2. The revised El Escorial criteria, meeting the criteria for clinically probable laboratory-supported ALS, clinically probable ALS, or clinically definite ALS. 3. King's clinical stage 1 to 3. 4. Baseline ALS Functional Rating Scale-Revised (ALSFRS-R) total score ≥30. 5. Baseline ALSFRS-R swallowing item score ≥3. The participant must not depend on a nasogastric tube, gastrostomy tube, or other enteral feeding support at screening or at the time of the first dose. The investigator must confirm that the participant can safely swallow the intact study tablets in the actual tablet formulation and planned single-dose quantity. 6. Percent-predicted forced vital capacity (FVC) ≥70% and percent-predicted slow vital capacity (SVC) ≥60%. 7. Participants may receive riluzole and/or intravenous edaravone concomitantly with the study treatment. For participants receiving riluzole, the dose must have been stable for at least 4 weeks before enrollment. For participants receiving intravenous edaravone, at least one treatment cycle must have been completed on a stable dosing regimen before enrollment. 8. The participant has the capacity to provide informed consent and has the cognitive and behavioral capacity required to complete the informed consent process, study visits, study assessments, and study treatment. 9. The participant is able to understand the study information, is willing to participate in the study, and provides written informed consent. Exclusion Criteria Participants will be excluded if any of the following criteria apply: 1. Previous tracheostomy or current use of noninvasive ventilation throughout the day. 2. Inability to swallow or tolerate oral medication at screening, or previous percutaneous endoscopic gastrostomy (PEG) placement. 3. Hepatic dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × the upper limit of normal (ULN), or renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \