HELICOBACTER PYLORI INFECTIONSPhase 4NCT07306988
Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota.
A Phase 4 study testing Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae and Vonoprazan-Amoxicillin with Berberine in people with HELICOBACTER PYLORI INFECTIONS and Metabolic Syndrome, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The Role of Gut Microbiota in the Mechanism of Helicobacter pylori Eradication-Induced Amelioration of Metabolic Syndrome-Related Parameters Study Sponsor: Nanjing First Hospital Principal Investigator: Dr. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS, Metabolic Syndrome
- What is being tested?
- Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae and Vonoprazan-Amoxicillin with Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2025to 30 Jun 2026
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For H. pylori-naïve infected patients with newly diagnosed metabolic syndrome (MS):
- Aged 18-65 years;
- Confirmed H. pylori-positive status by urea breath test (UBT), with no prior eradication therapy;
- Newly diagnosed MS according to the Chinese Diabetes Society (CDS, 2004 Chinese criteria) ;
- Voluntarily join the trial and sign informed consent.
- For H. pylori-negative healthy controls with normal metabolism:
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- Aged 18-65 years;
- Confirmed H. pylori-negative status by UBT;
- Normal metabolic parameters (e.g., blood glucose, lipid profile, blood pressure) without MS;
- Voluntarily join the trial and sign informed consent.
Who cannot join
- Hypersensitivity to study drugs (e.g., penicillin, amoxicillin, vonoprazan);
- Active peptic ulcer confirmed by endoscopy;
- Prior history of H. pylori eradication therapy;
- Use of medications for metabolic regulation (e.g., hypoglycemic agents, lipid-lowering drugs, weight-loss drugs)
- Recent use of antibiotics or bismuth (within 4 weeks) or H2-receptor antagonists/PPIs (within 2 weeks) before enrollment;
- Current use of corticosteroids, NSAIDs, or anticoagulants;
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- History of esophageal or gastric surgery;
- Pregnant or breastfeeding women;
- Severe comorbidities (e.g., hepatic, cardiovascular, pulmonary, renal diseases, inflammatory bowel disease);
- Chronic alcohol abuse (>40 g/day for men, >20 g/day for women);
- Malignancies (e.g., gastric mucosa-associated lymphoid tissue [MALT] lymphoma).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
Ruolin Peng, +86 15913195399, 3480502961@qq.com
About this study
Official title: Mechanisms of Gut Microbiota in Improving Metabolic Syndrome-Related Parameters Following Helicobacter Pylori Eradication
The Role of Gut Microbiota in the Mechanism of Helicobacter pylori Eradication-Induced Amelioration of Metabolic Syndrome-Related Parameters
Study Sponsor: Nanjing First Hospital Principal Investigator: Dr. Wanli Liu Department: Gastroenterology Study Duration: February 2025 - August 2025
Read more
Key Information for Patients and Families
- What is this study about? This study aims to understand how treating a common stomach infection caused by Helicobacter pylori (Hp) might improve metabolic health issues like high blood sugar, cholesterol problems, or obesity (collectively called metabolic syndrome). Specifically, it explores whether adding probiotics (good bacteria) or a natural compound called berberine (BBR) to standard Hp treatment can enhance these benefits by improving gut bacteria balance.
- Who can participate? Patients: Adults aged 18-65 with both Helicobacter pylori infection (confirmed by a breath test) and newly diagnosed metabolic syndrome (based on waist size, blood sugar, cholesterol, or blood pressure). Healthy Volunteers: Adults aged 18-65 with no Hp infection and normal metabolic health (to compare results). Exclusions: Allergy to study medications (e.g., penicillin). Previous Hp treatment, recent antibiotic/steroid use, pregnancy, or serious medical conditions (e.g., liver/kidney disease).
- What will participants do? Treatment Groups: Group A: Take two medications (vonoprazan + amoxicillin) for 14 days. Group B: Take the two medications + probiotics (Bifidobacterium tablets). Group C: Take the two medications + berberine (a plant-based supplement). Tests: Before treatment: Breath test, blood tests (blood sugar, cholesterol, inflammation markers), stool sample analysis (gut bacteria), and body measurements (weight, waist size). After treatment (1 month): Repeat tests to check Hp eradication and metabolic improvements.
- Possible Benefits and Risks Benefits: Free Hp treatment and metabolic health monitoring. Potential improvement in blood sugar, cholesterol, or weight. Contribution to future treatments for metabolic syndrome. Risks: Mild side effects (e.g., nausea, diarrhea, stomach pain) from medications. Discomfort from blood draws or stool sample collection.
- How are participants protected? All treatments are FDA-approved or widely used in clinical practice.
Ethical review ensures participant safety.
You can withdraw at any time without affecting your regular care.
Information for Health Care Providers
- Study Design Type: Prospective, single-center, open-label, randomized controlled trial. Population: 140 participants (120 Hp+ patients with metabolic syndrome; 20 Hp- healthy controls). Intervention: Group A: Vonoprazan (20 mg bid) + amoxicillin (1 g tid) for 14 days. Group B: Group A + Bifidobacterium tetragenous probiotic (3 tablets tid). Group C: Group A + berberine (3 tablets tid). Primary Outcomes: Hp eradication rate (confirmed by urea breath test). Changes in metabolic parameters (fasting glucose, HbA1c, lipid profile). Gut microbiota composition (16S rRNA sequencing). Secondary Outcomes: Multi-omics analysis (inflammation markers, endotoxins, short-chain fatty acids, bile acids).
- Scientific Rationale Hp and Metabolic Syndrome: Epidemiological evidence links Hp infection to metabolic dysfunction, possibly via chronic inflammation. Eradication may partially reverse insulin resistance and dyslipidemia. Gut Microbiota as Mediator: Hp eradication alters gut microbiota, which regulates metabolic homeostasis through metabolites (e.g., SCFAs), bile acid metabolism, and inflammatory pathways. Probiotics/BBR may enhance these effects.
- Methodology Randomization: Block randomization (block size = 4) using SAS 9.4. Assessments: Metabolic Parameters: Fasting glucose, HbA1c, lipid profile, BMI. Microbiome: 16S rRNA sequencing (α/β diversity, taxa abundance). Multi-omics: ELISA (TNF-α, IL-6), GC-MS (SCFAs), UPLC-MS (bile acids). Statistical Analysis: Microbiome: QIIME2, LEfSe, PICRUSt2. Multi-omics: limma, SparCC, sPLS-DA. Clinical data: ANOVA, χ² tests (SPSS v25.0).
- Clinical Implications Clarify whether probiotics or BBR add value to Hp eradication in improving metabolic health.
Identify gut microbiota-driven mechanisms linking Hp eradication to metabolic benefits.
Resources for Participants
Study Flowchart:
Screening: Breath test, blood/stool tests (1 week).
Treatment: 14 days of medication.
Follow-up: Repeat tests at 1 month.
Contact Information:
Dr. Wanli Liu: +86-18951670222
Nanjing First Hospital Gastroenterology Department.
FAQ Sheet:
Can I take my regular medications? Yes, unless they interfere with Hp treatment (e.g., PPIs).
What if I miss a dose? Contact the study team immediately.
Ethical Compliance Approved by the Institutional Review Board of Nanjing First Hospital.
Complies with the Declaration of Helsinki and China's ethical guidelines.
Informed consent required for participation.
- Conditions
- HELICOBACTER PYLORI INFECTIONS, Metabolic Syndrome
- Being tested
- Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae, Vonoprazan-Amoxicillin with Berberine
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan-Amoxicillin Dual TherapyDrug
Patients receive oral vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days. This regimen is a standard dual therapy for Helicobacter pylori eradication.
Vonoprazan-Amoxicillin with Bifidobacterium tetravaccaeDrug
Patients receive oral vonoprazan 20 mg twice daily, amoxicillin 1000 mg three times daily, and Bifidobacterium tetravaccae probiotic tablets (3 tablets three times daily) for 14 days.
Vonoprazan-Amoxicillin with BerberineDrug
Patients receive oral vonoprazan 20 mg twice daily, amoxicillin 1000 mg three times daily, and berberine hydrochloride tablets (3 tablets three times daily) for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| VA group | Experimental | Not described Receives: Drug: Vonoprazan-Amoxicillin Dual Therapy |
| Probiotics Group | Experimental | Not described Receives: Drug: Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae |
| BBR Group | Experimental | Not described Receives: Drug: Vonoprazan-Amoxicillin with Berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori Eradication Rate
Measured: Post-treatment follow-up at 1 month
Change in Serum Triglycerides
Measured: Baseline and 1 month post-treatment.
Change in HDL Cholesterol
Measured: Baseline and 1 month post-treatment.
Change in Blood Pressure
Measured: Baseline and 1 month post-treatment.
Change in Waist Circumference
Measured: Baseline and 1 month post-treatment.
Change in Fasting Plasma Glucose
Measured: Baseline and 1 month post-treatment.
Secondary outcomes (6)
Change in gut microbiota alpha-diversity, assessed by 16S rRNA gene sequencing
Measured: Baseline and 1 month post-treatment.
Change in gut microbiota beta-diversity, assessed by 16S rRNA gene sequencing
Measured: Baseline and 1 month post-treatment.
Identification of differentially abundant bacterial taxa (Genus level), assessed by 16S rRNA gene sequencing and statistical modeling (e.g., LEfSe or DESeq2)
Measured: Baseline and 1 month post-treatment.
Serum Levels of Inflammatory Cytokines (Including TNF-α, CRP, IL-6, and IL-8)
measured by enzyme-linked immunosorbent assay (ELISA) in serum.
Measured: Baseline and 1 month post-treatment.
Endotoxins
measured by limulus amebocyte lysate (LAL) assay in serum
Measured: Baseline and 1 month post-treatment.
Gut microbiota-derived metabolites
measured by liquid chromatography-mass spectrometry (LC-MS)
Measured: Baseline and 1 month post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start17 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306988
- Sponsor's protocol ID
- KY20250327-12
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2025
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Gut Microbiota in Improving Metabolic Syndrome-Related Parameters Following Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT07306988
- Acronym / sponsor ID
- KY20250327-12
- Conditions
- HELICOBACTER PYLORI INFECTIONS, Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
The Role of Gut Microbiota in the Mechanism of Helicobacter pylori Eradication-Induced Amelioration of Metabolic Syndrome-Related Parameters
Study Sponsor: Nanjing First Hospital Principal Investigator: Dr. Wanli Liu Department: Gastroenterology Study Duration: February 2025 - August 2025
Key Information for Patients and Families
- What is this study about? This study aims to understand how treating a common stomach infection caused by Helicobacter pylori (Hp) might improve metabolic health issues like high blood sugar, cholesterol problems, or obesity (collectively called metabolic syndrome). Specifically, it explores whether adding probiotics (good bacteria) or a natural compound called berberine (BBR) to standard Hp treatment can enhance these benefits by improving gut bacteria balance.
- Who can participate? Patients: Adults aged 18-65 with both Helicobacter pylori infection (confirmed by a breath test) and newly diagnosed metabolic syndrome (based on waist size, blood sugar, cholesterol, or blood pressure). Healthy Volunteers: Adults aged 18-65 with no Hp infection and normal metabolic health (to compare results). Exclusions: Allergy to study medications (e.g., penicillin). Previous Hp treatment, recent antibiotic/steroid use, pregnancy, or serious medical conditions (e.g., liver/kidney disease).
- What will participants do? Treatment Groups: Group A: Take two medications (vonoprazan + amoxicillin) for 14 days. Group B: Take the two medications + probiotics (Bifidobacterium tablets). Group C: Take the two medications + berberine (a plant-based supplement). Tests: Before treatment: Breath test, blood tests (blood sugar, cholesterol, inflammation markers), stool sample analysis (gut bacteria), and body measurements (weight, waist size). After treatment (1 month): Repeat tests to check Hp eradication and metabolic improvements.
- Possible Benefits and Risks Benefits: Free Hp treatment and metabolic health monitoring. Potential improvement in blood sugar, cholesterol, or weight. Contribution to future treatments for metabolic syndrome. Risks: Mild side effects (e.g., nausea, diarrhea, stomach pain) from medications. Discomfort from blood draws or stool sample collection.
- How are participants protected? All treatments are FDA-approved or widely used in clinical practice.
Ethical review ensures participant safety.
You can withdraw at any time without affecting your regular care.
Information for Health Care Providers
- Study Design Type: Prospective, single-center, open-label, randomized controlled trial. Population: 140 participants (120 Hp+ patients with metabolic syndrome; 20 Hp- healthy controls). Intervention: Group A: Vonoprazan (20 mg bid) + amoxicillin (1 g tid) for 14 days. Group B: Group A + Bifidobacterium tetragenous probiotic (3 tablets tid). Group C: Group A + berberine (3 tablets tid). Primary Outcomes: Hp eradication rate (confirmed by urea breath test). Changes in metabolic parameters (fasting glucose, HbA1c, lipid profile). Gut microbiota composition (16S rRNA sequencing). Secondary Outcomes: Multi-omics analysis (inflammation markers, endotoxins, short-chain fatty acids, bile acids).
- Scientific Rationale Hp and Metabolic Syndrome: Epidemiological evidence links Hp infection to metabolic dysfunction, possibly via chronic inflammation. Eradication may partially reverse insulin resistance and dyslipidemia. Gut Microbiota as Mediator: Hp eradication alters gut microbiota, which regulates metabolic homeostasis through metabolites (e.g., SCFAs), bile acid metabolism, and inflammatory pathways. Probiotics/BBR may enhance these effects.
- Methodology Randomization: Block randomization (block size = 4) using SAS 9.4. Assessments: Metabolic Parameters: Fasting glucose, HbA1c, lipid profile, BMI. Microbiome: 16S rRNA sequencing (α/β diversity, taxa abundance). Multi-omics: ELISA (TNF-α, IL-6), GC-MS (SCFAs), UPLC-MS (bile acids). Statistical Analysis: Microbiome: QIIME2, LEfSe, PICRUSt2. Multi-omics: limma, SparCC, sPLS-DA. Clinical data: ANOVA, χ² tests (SPSS v25.0).
- Clinical Implications Clarify whether probiotics or BBR add value to Hp eradication in improving metabolic health.
Identify gut microbiota-driven mechanisms linking Hp eradication to metabolic benefits.
Resources for Participants
Study Flowchart:
Screening: Breath test, blood/stool tests (1 week).
Treatment: 14 days of medication.
Follow-up: Repeat tests at 1 month.
Contact Information:
Dr. Wanli Liu: +86-18951670222
Nanjing First Hospital Gastroenterology Department.
FAQ Sheet:
Can I take my regular medications? Yes, unless they interfere with Hp treatment (e.g., PPIs).
What if I miss a dose? Contact the study team immediately.
Ethical Compliance Approved by the Institutional Review Board of Nanjing First Hospital.
Complies with the Declaration of Helsinki and China's ethical guidelines.
Informed consent required for participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VA group | Experimental | Drug: Vonoprazan-Amoxicillin Dual Therapy |
| Probiotics Group | Experimental | Drug: Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae |
| BBR Group | Experimental | Drug: Vonoprazan-Amoxicillin with Berberine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For H. pylori-naïve infected patients with newly diagnosed metabolic syndrome (MS):
- For H. pylori-negative healthy controls with normal metabolism:
Key exclusion criteria (11 listed)
- Hypersensitivity to study drugs (e.g., penicillin, amoxicillin, vonoprazan);
- Active peptic ulcer confirmed by endoscopy;
- Prior history of H. pylori eradication therapy;
- Use of medications for metabolic regulation (e.g., hypoglycemic agents, lipid-lowering drugs, weight-loss drugs)
- Recent use of antibiotics or bismuth (within 4 weeks) or H2-receptor antagonists/PPIs (within 2 weeks) before enrollment;
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 |
|---|---|---|
| Vonoprazan-Amoxicillin Dual TherapyPatients receive oral vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days. This regimen is a standard dual therapy for Helicobacter pylori eradication. | Drug | VA group |
| Vonoprazan-Amoxicillin with Bifidobacterium tetravaccaePatients receive oral vonoprazan 20 mg twice daily, amoxicillin 1000 mg three times daily, and Bifidobacterium tetravaccae probiotic tablets (3 tablets three times daily) for 14 days. | Drug | Probiotics Group |
| Vonoprazan-Amoxicillin with BerberinePatients receive oral vonoprazan 20 mg twice daily, amoxicillin 1000 mg three times daily, and berberine hydrochloride tablets (3 tablets three times daily) for 14 days. | Drug | BBR Group |
Primary outcome
Helicobacter pylori Eradication Rate
Time frame: Post-treatment follow-up at 1 month
Change in Serum Triglycerides
Time frame: Baseline and 1 month post-treatment.
Change in HDL Cholesterol
Time frame: Baseline and 1 month post-treatment.
Change in Blood Pressure
Time frame: Baseline and 1 month post-treatment.
Change in Waist Circumference
Time frame: Baseline and 1 month post-treatment.
Change in Fasting Plasma Glucose
Time frame: Baseline and 1 month post-treatment.
6 secondary outcomes
Change in gut microbiota alpha-diversity, assessed by 16S rRNA gene sequencing
Time frame: Baseline and 1 month post-treatment.
Change in gut microbiota beta-diversity, assessed by 16S rRNA gene sequencing
Time frame: Baseline and 1 month post-treatment.
Identification of differentially abundant bacterial taxa (Genus level), assessed by 16S rRNA gene sequencing and statistical modeling (e.g., LEfSe or DESeq2)
Time frame: Baseline and 1 month post-treatment.
Serum Levels of Inflammatory Cytokines (Including TNF-α, CRP, IL-6, and IL-8)
Time frame: Baseline and 1 month post-treatment.
Endotoxins
Time frame: Baseline and 1 month post-treatment.
Gut microbiota-derived metabolites
Time frame: Baseline and 1 month post-treatment.
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 13 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae and Vonoprazan-Amoxicillin with Berberine in people with HELICOBACTER PYLORI INFECTIONS and Metabolic Syndrome, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Wanli Liu (+86 18951768998, 18951768998@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori Eradication Rate (time frame: Post-treatment follow-up at 1 month). 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?
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 13 Apr 2026.