Non-Alcoholic Fatty Liver DiseasePhase 1/2NCT04555434
Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH
A Phase 1/2 study testing Probiotics in people with Non-Alcoholic Fatty Liver Disease and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
A study for evaluating the improvement effect on Metabolic dysfunction-associated steatotic liver disease (MASLD) of probiotics Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with dysbiosis of the gut microbiota and altered host metabolic homeostasis. Read more about this study
- Who is it for?
- Ages 21 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Sep 2020to 1 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 21 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who agreed to participate in this study and signed a written consent
- Adult men and women over 20
- Patients diagnosed with non-alcoholic fatty liver
- ※ Exclusion criteria for alcoholic liver disease
- Those who have an alcoholic drinking ability of at least 60g per day for at least one year before visiting (30g for women)
- 1 bottle of shochu 360 ml * 20% = 72 g, 1 bottle of beer 500 ml (330 ml for commercial use) * 5% = 25 (16.5 g)
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- Patients with higher liver numbers than normal ※ Adult normal liver level range by enzyme
- AST, ALT: 40 or less
- ALP: 20-130
- GOT: 0-30, GPT: 0-38
- GGT: 10-62 (male), 7-35 (female)
Who cannot join
- Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month.
- Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period
- Those who have continuously consumed medicines or health functional foods that affect liver function within the past month.
- Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials)
- If you have any of the following
- Alcoholic liver disease, hereditary metabolic disease, autoimmune hepatitis
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- systemic inflammatory disease or immune disease
- Hepatocellular carcinoma
- Uncontrolled cardiopulmonary disease
- Other serious systemic disorders in the heart, lungs, blood, and endocrine system
- A person with a history of malignancy diagnosis within the last 5 years
- Pregnant or lactating women
- Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions
- Those who are not suitable for the clinical trial because the investigator judges
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 200-704
About this study
Official title: Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in Patients With Nonalcoholic Hepatitis
A study for evaluating the improvement effect on Metabolic dysfunction-associated steatotic liver disease (MASLD) of probiotics
Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with dysbiosis of the gut microbiota and altered host metabolic homeostasis. Probiotics have been proposed as a potential therapeutic strategy to modulate gut microbial composition and improve metabolic and hepatic outcomes in MASLD; however, clinical evidence regarding next-generation probiotic strains remains limited.
Read more
This study was designed to evaluate the effects of three next-generation probiotic strains-Lactobacillus delbrueckii subsp. lactis (LL001), Lactobacillus helveticus (LH001), and Pediococcus pentosaceus KID7 (PPKID7)-on liver function parameters and gut microbiome composition in patients with MASLD.
We conducted a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 110 adult patients diagnosed with MASLD were screened for eligibility. Eligible participants were randomly assigned to receive one of the three probiotic formulations (3 capsules per day, total 9×10⁹ CFU) or placebo for 8 weeks. All participants received concomitant silymarin during the intervention period.
Clinical assessments, serum samples, and stool samples were collected at baseline and at the end of the intervention. Liver function parameters were predefined as the primary outcome measure. Secondary outcomes included changes in anthropometric parameters, serum metabolic markers, gut microbiota composition assessed by 16S rRNA gene sequencing, and lipidomic profiles derived from serum and fecal samples. Compliance was monitored throughout the study period.
The study protocol was approved by the institutional review board, and written informed consent was obtained from all participants prior to enrollment.
Read the detailed description
Metabolic dysfunction-associated fatty liver disease applies to adults exhibiting hepatic steatosis identified through imaging techniques, blood biomarkers, or liver histology. This diagnosis is made in individuals who are overweight or obese, or who have type 2 diabetes mellitus, or at least two other metabolic risk abnormalities. Subsequently, in June 2023, a multi-society Delphi consensus statement was issued on a revised nomenclature for fatty liver diseases. This statement introduced the term metabolic dysfunction-associated steatotic liver disease (MASLD), effectively replacing the previous nonalcoholic fatty liver disease. Representative etiologies of MASLD are known to include insulin resistance, lipid toxicity due to excessive fat accumulation, inflammatory response, and endoplasmic reticulum stress.
The global rise in obesity has contributed to the increased prevalence of MASLD. MASLD affects approximately 30% of the global adult population, with its prevalence rising from 22% to 37% between 1991 and 2019. This increase aligns with the growing rates of obesity and related conditions worldwide. The more severe manifestation of MASLD, known as metabolic dysfunction-associated steatohepatitis (MASH), is histologically characterized by lobular inflammation and hepatocyte ballooning and is linked to a higher risk of fibrosis progression. Among individuals diagnosed with MASLD who do not meet criteria for a liver biopsy, the prevalence of MASH is approximately 7%. MASLD is one of the most common causes of chronic liver disease and liver-related death and serves as a risk factor for extrahepatic diseases such as diabetes and cardiovascular disease. As a result, the burden of social and economic costs caused by the disease is increasing.
Recently, interest in the role of the gut microbiome in the pathogenesis and treatment of liver diseases has increased, and the disease linkage caused by intestinal bacterial imbalance has been identified [16, 17]. Animal studies have demonstrated potential causal roles of the gut microbiota in MASLD [18, 19]. Human studies have described microbiome alterations in healthy individuals and patients with MASLD and have found several consistent specific taxa that differentiate between healthy individuals and patients with MASLD and advanced liver disease. Despite unknown mechanisms and lack of validation, therapeutic strategies utilizing the gut microbiome have the potential to provide beneficial effects in patients with MASLD.
Probiotics are live microorganisms that, when administered in adequate amounts, provide health benefits to the host. In our previous animal studies, Lactobacillus and Pediococcus supplementation improved MASLD by modulating gut microbiota and inflammation. Additional experiments with candidate strains have shown promising results in the prevention of MASLD progression. Several randomized controlled trials using ultrasonography and MASLD diagnostic markers of short duration have suggested that administration of probiotics may have a positive effect on hepatic steatosis and insulin resistance in patients. However, none of the previous studies reported the therapeutic effect of probiotics on the microbiome in patients with MASLD. In this clinical trial, we aimed to investigate whether administering probiotics for 8 weeks could effectively improve blood biochemical parameters and induce alterations in the gut microbiota among patients diagnosed with MASLD.
- Conditions
- Non-Alcoholic Fatty Liver Disease, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Being tested
- Probiotics
- Keywords
- Probiotics, Liver disease, Gut microbiota
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called Cellulose (Placebo)
- Experimental group Main ingredients: P. pentosaceus KID7, L. lactis CKDB001 or L. helveticus CKDB001 (containing 9 × 10^9 CFU / day)
- Control group Main ingredient: Crystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | The selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations. Receives: Dietary Supplement: Probiotics |
| Placebo group | Placebo comparator | The selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations. Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristics
The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY
Measured: 1 week
Primary Outcomes; Liver Function Test
Primary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Measured: Baseline of AST, ALT, rGT, CHOL, and ALP at first week.
Gut-Microbiome Composition
Change of the species and proportions of the gut microbiome. Proportion of phyrum level Composition of F/B ratio
Measured: Change from Baseline of fecal microbiome at 8 months
Computed Tomography
change of the Abdominal ultrasonography or Computed Tomography(CT): Upper abdominal ultrasound or CT to determine the degree of fatty liver disease
② Fibroscan: Objectively and quantitatively grasp the degree of liver fibrosis by measuring the degree of firmness (elasticity) of the liver
Measured: Change from Baseline of CT image at 8 months
change of BMI
Compare the body mass index. BMI=Body Weight/(Height)^2
Measured: Change from Baseline BMI and weight at 6 months
Secondary Outcomes; Liver Function Test
Secondary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Measured: Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start20 Sep 2020
- Primary completion11 Sep 2022
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluates the effect of probiotic improvement on non-alcoholic fatty liver disease in patients diagnosed with non-alcoholic fatty liver disease.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Responsible party
- Principal investigator, Ki Tae Suk, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555434
- Sponsor's protocol ID
- PRO-NASH
- Status last verified
- Feb 2026
- First submitted
- 1 Jul 2020
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Personal data is regulated by IRB
Publications
Won SM, Joung H, Park IG, Han SH, Ham YL, Han JS, Kwon Y, Kim DJ, Suk KT. The effects of next generation probiotics on metabolic dysfunction-associated steatotic liver disease: a parallel, double-blind, randomized, placebo-controlled trial. J Transl Med. 2025 Dec 9;24(1):61. doi: 10.1186/s12967-025-07478-z.
PubMed 41366779
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in Patients With Nonalcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT04555434
- Acronym / sponsor ID
- PRO-NASH
- Conditions
- Non-Alcoholic Fatty Liver Disease, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Keywords
- Probiotics, Liver disease, Gut microbiota
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 18 Sep 2020 (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.
A study for evaluating the improvement effect on Metabolic dysfunction-associated steatotic liver disease (MASLD) of probiotics
Metabolic dysfunction-associated steatotic liver disease (MASLD) is associated with dysbiosis of the gut microbiota and altered host metabolic homeostasis. Probiotics have been proposed as a potential therapeutic strategy to modulate gut microbial composition and improve metabolic and hepatic outcomes in MASLD; however, clinical evidence regarding next-generation probiotic strains remains limited.
This study was designed to evaluate the effects of three next-generation probiotic strains-Lactobacillus delbrueckii subsp. lactis (LL001), Lactobacillus helveticus (LH001), and Pediococcus pentosaceus KID7 (PPKID7)-on liver function parameters and gut microbiome composition in patients with MASLD.
We conducted a randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 110 adult patients diagnosed with MASLD were screened for eligibility. Eligible participants were randomly assigned to receive one of the three probiotic formulations (3 capsules per day, total 9×10⁹ CFU) or placebo for 8 weeks. All participants received concomitant silymarin during the intervention period.
Clinical assessments, serum samples, and stool samples were collected at baseline and at the end of the intervention. Liver function parameters were predefined as the primary outcome measure. Secondary outcomes included changes in anthropometric parameters, serum metabolic markers, gut microbiota composition assessed by 16S rRNA gene sequencing, and lipidomic profiles derived from serum and fecal samples. Compliance was monitored throughout the study period.
The study protocol was approved by the institutional review board, and written informed consent was obtained from all participants prior to enrollment.
Detailed description
Metabolic dysfunction-associated fatty liver disease applies to adults exhibiting hepatic steatosis identified through imaging techniques, blood biomarkers, or liver histology. This diagnosis is made in individuals who are overweight or obese, or who have type 2 diabetes mellitus, or at least two other metabolic risk abnormalities. Subsequently, in June 2023, a multi-society Delphi consensus statement was issued on a revised nomenclature for fatty liver diseases. This statement introduced the term metabolic dysfunction-associated steatotic liver disease (MASLD), effectively replacing the previous nonalcoholic fatty liver disease. Representative etiologies of MASLD are known to include insulin resistance, lipid toxicity due to excessive fat accumulation, inflammatory response, and endoplasmic reticulum stress.
The global rise in obesity has contributed to the increased prevalence of MASLD. MASLD affects approximately 30% of the global adult population, with its prevalence rising from 22% to 37% between 1991 and 2019. This increase aligns with the growing rates of obesity and related conditions worldwide. The more severe manifestation of MASLD, known as metabolic dysfunction-associated steatohepatitis (MASH), is histologically characterized by lobular inflammation and hepatocyte ballooning and is linked to a higher risk of fibrosis progression. Among individuals diagnosed with MASLD who do not meet criteria for a liver biopsy, the prevalence of MASH is approximately 7%. MASLD is one of the most common causes of chronic liver disease and liver-related death and serves as a risk factor for extrahepatic diseases such as diabetes and cardiovascular disease. As a result, the burden of social and economic costs caused by the disease is increasing.
Recently, interest in the role of the gut microbiome in the pathogenesis and treatment of liver diseases has increased, and the disease linkage caused by intestinal bacterial imbalance has been identified [16, 17]. Animal studies have demonstrated potential causal roles of the gut microbiota in MASLD [18, 19]. Human studies have described microbiome alterations in healthy individuals and patients with MASLD and have found several consistent specific taxa that differentiate between healthy individuals and patients with MASLD and advanced liver disease. Despite unknown mechanisms and lack of validation, therapeutic strategies utilizing the gut microbiome have the potential to provide beneficial effects in patients with MASLD.
Probiotics are live microorganisms that, when administered in adequate amounts, provide health benefits to the host. In our previous animal studies, Lactobacillus and Pediococcus supplementation improved MASLD by modulating gut microbiota and inflammation. Additional experiments with candidate strains have shown promising results in the prevention of MASLD progression. Several randomized controlled trials using ultrasonography and MASLD diagnostic markers of short duration have suggested that administration of probiotics may have a positive effect on hepatic steatosis and insulin resistance in patients. However, none of the previous studies reported the therapeutic effect of probiotics on the microbiome in patients with MASLD. In this clinical trial, we aimed to investigate whether administering probiotics for 8 weeks could effectively improve blood biochemical parameters and induce alterations in the gut microbiota among patients diagnosed with MASLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Evaluates the effect of probiotic improvement on non-alcoholic fatty liver disease in patients diagnosed with non-alcoholic fatty liver disease.
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Experimental | Dietary Supplement: ProbioticsThe selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations. |
| Placebo group | Placebo comparator | Dietary Supplement: ProbioticsThe selected test subjects were randomly assigned to test group 1, test group 2, test group 3, or control group according to the order registered at visit 2 (week 0) after a 2-week run-in period, and for 8 weeks, the study drug or study After taking the treaty, analyze the results of the observations. |
Who may qualify
- Ages
- 21 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Those who agreed to participate in this study and signed a written consent
- Adult men and women over 20
- Patients diagnosed with non-alcoholic fatty liver
- ※ Exclusion criteria for alcoholic liver disease
- Patients with higher liver numbers than normal ※ Adult normal liver level range by enzyme
Key exclusion criteria (14 listed)
- Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month.
- Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period
- Those who have continuously consumed medicines or health functional foods that affect liver function within the past month.
- Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials)
- If you have any of the following
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 |
|---|---|---|
| ProbioticsAlso: Cellulose (Placebo)* Experimental group Main ingredients: P. pentosaceus KID7, L. lactis CKDB001 or L. helveticus CKDB001 (containing 9 × 10^9 CFU / day) * Control group Main ingredient: Crystalline cellulose | Dietary supplement | Placebo group, Probiotics group |
Primary outcome
Demographic characteristics
Time frame: 1 week
The gender, date of birth, age, menstruation, and amenorrhea, FAMILY HISTORY
Primary Outcomes; Liver Function Test
Time frame: Baseline of AST, ALT, rGT, CHOL, and ALP at first week.
Primary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Gut-Microbiome Composition
Time frame: Change from Baseline of fecal microbiome at 8 months
Change of the species and proportions of the gut microbiome. Proportion of phyrum level Composition of F/B ratio
Computed Tomography
Time frame: Change from Baseline of CT image at 8 months
change of the Abdominal ultrasonography or Computed Tomography(CT): Upper abdominal ultrasound or CT to determine the degree of fatty liver disease ② Fibroscan: Objectively and quantitatively grasp the degree of liver fibrosis by measuring the degree of firmness (elasticity) of the liver
change of BMI
Time frame: Change from Baseline BMI and weight at 6 months
Compare the body mass index. BMI=Body Weight/(Height)^2
Secondary Outcomes; Liver Function Test
Time frame: Change from Baseline of AST, ALT, rGT, CHOL, and ALP at 8 months
Secondary outcomes of liver function enzyme level (AST, ALT, rGT, CHOL, ALP)[IU/L]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Derived from this study: PubMed 41366779Won SM, Joung H, Park IG, Han SH, Ham YL, Han JS, Kwon Y, Kim DJ, Suk KT. The effects of next generation probiotics on metabolic dysfunction-associated steatotic liver disease: a parallel, double-blind, randomized, placebo-controlled trial. J Transl Med. 2025 Dec 9;24(1):61. doi: 10.1186/s12967-025-07478-z.
- Individual participant dataSharing planned: Undecided. Personal data is regulated by IRB
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Probiotics in people with Non-Alcoholic Fatty Liver Disease and MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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 14 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: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demographic characteristics (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555434, which also lists 1 linked publication.
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 20 Feb 2026.