Amyotrophic Lateral Sclerosis (ALS)NCT07922031
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
A study testing Sulforaphane and Bacillus coagulans GBI-30, 6086 in people with Amyotrophic Lateral Sclerosis (ALS) and Bacillus Coagulans, run by Liu Qing.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans, Dietary Supplement
- What is being tested?
- Sulforaphane and Bacillus coagulans GBI-30, 6086
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- The Gold Coast diagnostic criteria for ALS; or
- The revised El Escorial criteria, meeting the criteria for clinically probable laboratory-supported ALS, clinically probable ALS, or clinically definite ALS.
- King's clinical stage 1 to 3.
- Baseline ALS Functional Rating Scale-Revised (ALSFRS-R) total score ≥30.
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- 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.
- Percent-predicted forced vital capacity (FVC) ≥70% and percent-predicted slow vital capacity (SVC) ≥60%.
- 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.
- 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.
- The participant is able to understand the study information, is willing to participate in the study, and provides written informed consent.
Who cannot join
- Participants will be excluded if any of the following criteria apply:
- Previous tracheostomy or current use of noninvasive ventilation throughout the day.
- Inability to swallow or tolerate oral medication at screening, or previous percutaneous endoscopic gastrostomy (PEG) placement.
- 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) <45 mL/min/1.73 m².
- Coagulation disorder or current anticoagulant therapy.
- A clinically significant gastrointestinal condition, such as chronic diarrhea, intestinal obstruction, or previous gastrectomy, that may affect gastrointestinal function.
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- Pregnancy or breastfeeding, or unwillingness to use contraception during the study in women of childbearing potential.
- A history of malignancy within the previous 5 years.
- Severe cognitive impairment or severe psychiatric illness.
- Any other serious systemic disease.
- Life expectancy of less than 6 months due to a non-ALS cause.
- Current participation in another interventional clinical trial.
- Inability to comply with all required study visits and assessments.
- Known allergy or hypersensitivity to any component of the study treatment.
- Any other clinically significant medical condition that may place the participant at risk, interfere with the assessment of study safety, or increase the risk of death during the study.
About this study
Official title: A Pilot, Randomized, Single-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Alsum30 in Subjects With 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.
Read the detailed description
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.
- Being tested
- Sulforaphane and Bacillus coagulans GBI-30, 6086
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulforaphane and Bacillus coagulans GBI-30, 6086Dietary supplement
Alsum30 is a combination dietary supplement containing:
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group ( Alsum30 Add-on Treatment) | Experimental | Not described Receives: Dietary Supplement: Sulforaphane and Bacillus coagulans GBI-30, 6086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0) and Weeks 4, 12, 24, and 28
Secondary outcomes (7)
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.
Measured: 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%).
Measured: 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%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Qing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Qing, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922031
- Sponsor's protocol ID
- I-26PJ1884
- Status last verified
- Nov 2026
- First submitted
- 29 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Single-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Alsum30 in Subjects With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT07922031
- Acronym / sponsor ID
- I-26PJ1884
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Liu QingUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group ( Alsum30 Add-on Treatment) | Experimental | Dietary Supplement: Sulforaphane and Bacillus coagulans GBI-30, 6086 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- The Gold Coast diagnostic criteria for ALS; or
- The revised El Escorial criteria, meeting the criteria for clinically probable laboratory-supported ALS, clinically probable ALS, or clinically definite ALS.
- King's clinical stage 1 to 3.
- Baseline ALS Functional Rating Scale-Revised (ALSFRS-R) total score ≥30.
Key exclusion criteria (15 listed)
- Previous tracheostomy or current use of noninvasive ventilation throughout the day.
- Inability to swallow or tolerate oral medication at screening, or previous percutaneous endoscopic gastrostomy (PEG) placement.
- 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) <45 mL/min/1.73 m².
- Coagulation disorder or current anticoagulant therapy.
- A clinically significant gastrointestinal condition, such as chronic diarrhea, intestinal obstruction, or previous gastrectomy, that may affect gastrointestinal function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulforaphane and Bacillus coagulans GBI-30, 6086Alsum30 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. | Dietary supplement | Experimental group ( Alsum30 Add-on Treatment) |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From first dose through 4 weeks after the last dose
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.
Number of Participants With Serious Adverse Events
Time frame: From first dose through 4 weeks after the last dose
The number of participants with at least one serious adverse event during the safety observation period.
Number of Participants Who Discontinue Study Treatment Early
Time frame: From first dose through Week 24
The number of participants who permanently discontinue Alsum30 before completing the planned 24-week treatment period, for any reason.
Number of Participants Who Discontinue Study Treatment Early Due to Adverse Events
Time frame: From first dose through Week 24
The number of participants who permanently discontinue Alsum30 before completing the planned 24-week treatment period because of an adverse event.
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline (Week 0) and Weeks 4, 12, 24, and 28
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.
7 secondary outcomes
Change From Baseline in ALS Functional Rating Scale-Revised Total Score
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Change From Baseline in Forced Vital Capacity Percent Predicted
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Change From Baseline in Slow Vital Capacity Percent Predicted
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Percentage of Participants Alive at Week 24
Time frame: From first dose through Week 24
Percentage of Participants Alive Without Respiratory Insufficiency at Week 24
Time frame: From first dose through Week 24
Percentage of Participants Alive Without Respiratory Insufficiency or ALS-Related Hospitalization at Week 24
Time frame: From first dose through Week 24
Change From Baseline in ALS Assessment Questionnaire-40 Domain Scores
Time frame: Week -6, baseline (Week 0), and Weeks 4, 12, and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sulforaphane and Bacillus coagulans GBI-30, 6086 in people with Amyotrophic Lateral Sclerosis (ALS) and Bacillus Coagulans, run by Liu Qing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (time frame: From first dose through 4 weeks after the last dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.