An interventional study of Sulforaphane and Bacillus coagulans GBI-30, 6086 in Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans and Dietary Supplement, sponsored by Liu Qing. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Liu Qing · Not applicable, Interventional, and Treatment
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.
At protocol-specified visits, participants may be offered additional blood, urine, stool, or saliva sample collection for optional exploratory research. Potential analyses include sulforaphane exposure, Nrf2-pathway gene expression, markers of inflammation and oxidative stress, and gut microbiota and related metabolites. Participants may decline optional sample collection. Collected samples may be stored without immediate testing, and some may not be tested if funding, assay capacity, or sample quality does not permit the planned analyses. Any testing will remain within the scope of participant consent and ethics approval.
979 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 278 are open to participants now.
This study's planned enrollment of 15 is below the median of 38 across 663 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Liu Qing is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria
Participants will be excluded if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Sulforaphane and Bacillus coagulans GBI-30, 6086
Alsum30 is a combination dietary supplement containing: 1. The sulforaphane(SF) will be supplied as glucoraphanin (GR)-enriched broccoli seed extract tablets. Each tablet contains 800 mg, of which 300 mg is broccoli seed extract (containing 40 mg GR, equivalent to approximately 91.4 µmol GR). Dosing will be escalated starting at 1 tablet daily, increasing by 1 tablet every 2 days until the target dose of 4 tablets daily (2 tablets twice daily) is reached. If gastrointestinal intolerance occurs, the dose will be reduced to the previous tolerable level. 2. BC30 (Bacillus coagulans GBI-30, 6086; GanedenBC30®) probiotic powder in sachets, each sachet labeled to contain no less than 1×10⁹ CFU as determined at end of shelf life. Administered orally twice daily, one sachet per dose, with room-temperature water or direct oral intake. Total daily dose: 2×10⁹ CFU. Treatment duration: 6 months.
Number of Participants With Treatment-Emergent Adverse Events
The number of participants with at least one adverse event that begins or worsens after the first dose of Alsum30. Events will be graded according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0). Incidence and severity will be summarized.
Time frame: From first dose through 4 weeks after the last dose
Number of Participants With Serious Adverse Events
The number of participants with at least one serious adverse event during the safety observation period.
Time frame: From first dose through 4 weeks after the last dose
Number of Participants Who Discontinue Study Treatment Early
The number of participants who permanently discontinue Alsum30 before completing the planned 24-week treatment period, for any reason.
Time frame: From first dose through Week 24
Number of Participants Who Discontinue Study Treatment Early Due to Adverse Events
The number of participants who permanently discontinue Alsum30 before completing the planned 24-week treatment period because of an adverse event.
Time frame: From first dose through Week 24
Number of Participants With Clinically Significant Laboratory Abnormalities
The number of participants with a new or worsening laboratory abnormality after the first dose that the investigator judges to be clinically significant. Scheduled safety laboratory assessments include hematology, liver function, renal function, coagulation, C-reactive protein, muscle enzymes, and fasting glucose.
Time frame: Baseline (Week 0) and Weeks 4, 12, 24, and 28
Change From Baseline in ALS Functional Rating Scale-Revised Total Score
Change from the Week 0 score at each post-baseline assessment. The ALS Functional Rating Scale-Revised (ALSFRS-R) total score ranges from 0 to 48; higher scores indicate better function. A Week -6 assessment is collected during the pretreatment run-in period.
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Change From Baseline in Forced Vital Capacity Percent Predicted
Change from the Week 0 value in forced vital capacity, expressed as a percentage of the predicted value (FVC%).
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Change From Baseline in Slow Vital Capacity Percent Predicted
Change from the Week 0 value in slow vital capacity, expressed as a percentage of the predicted value (SVC%).
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Percentage of Participants Alive at Week 24
The percentage of participants who are alive 24 weeks after starting study treatment.
Time frame: From first dose through Week 24
Percentage of Participants Alive Without Respiratory Insufficiency at Week 24
The percentage of participants who have neither died nor developed respiratory insufficiency by Week 24. Respiratory insufficiency is defined as tracheostomy or use of noninvasive ventilation for at least 22 hours per day for at least 10 consecutive days.
Time frame: From first dose through Week 24
Percentage of Participants Alive Without Respiratory Insufficiency or ALS-Related Hospitalization at Week 24
The percentage of participants who, by Week 24, have not died, developed respiratory insufficiency, or been hospitalized because of an amyotrophic lateral sclerosis (ALS)-related complication. Respiratory insufficiency is defined as tracheostomy or use of noninvasive ventilation for at least 22 hours per day for at least 10 consecutive days.
Time frame: From first dose through Week 24
Change From Baseline in ALS Assessment Questionnaire-40 Domain Scores
Change from Week 0 in the five ALS Assessment Questionnaire-40 (ALSAQ-40) domain scores: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions. Each domain is scored from 0 to 100; higher scores indicate worse health status. A Week -6 assessment is collected during the pretreatment run-in period.
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Change From Baseline in Edinburgh Cognitive and Behavioural ALS Screen Total Score
Change from the Week 0 Edinburgh Cognitive and Behavioural ALS Screen (ECAS) cognitive total score. The total score ranges from 0 to 136; higher scores indicate better cognitive performance. A Week -6 assessment is collected during the pretreatment run-in period.
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Change From Baseline in Plasma Neurofilament Light Chain Concentration
Change from the Week 0 concentration of plasma neurofilament light chain (NfL) at each post-baseline assessment.
Time frame: Baseline (Week 0) and Weeks 4, 12, and 24
Change From Baseline in Plasma Glial Fibrillary Acidic Protein Concentration
Change from the Week 0 concentration of plasma glial fibrillary acidic protein (GFAP) at each post-baseline assessment.
Time frame: Baseline (Week 0) and Weeks 4, 12, and 24
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 134 non-industry interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 25 months is below that.
Counting every sponsor, half of 154 studies reached it within 35 months; a quarter within 23 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →