Obesity and Obesity-related Medical ConditionsProbioticNCT07031596
Study on the Weight Loss Effects and Mechanisms of Probiotic Preparation Intervention in Weight Cyclers
A study testing WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100). and WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food. in people with Obesity and Obesity-related Medical Conditions, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
1. Study Background and Purpose Obesity is a complex chronic disease closely linked to comorbidities such as cardiovascular disease, hypertension, and diabetes. With lifestyle changes, obesity prevalence continues to rise. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100). and WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Jun 2025to Dec 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obesity : BMI ≥28 kg/m² and <35 kg/m².
- Weight Cycling History :
- Documented weight loss attempts within the past 2 years (≥3 episodes) with ≥5% body weight fluctuation.
- Age : 18-60 years (inclusive), male or female.
- Comprehension and Voluntariness : Ability to understand the weight loss protocol and willingness to complete the full study.
- Informed Consent : Signed informed consent form.
Who cannot join
- Weight-Loss Medications : Current use of medications affecting weight (e.g., orlistat, GLP-1 receptor agonists, metformin).
- Diabetes Mellitus : Diagnosed diabetes or use of antidiabetic medications.
- Severe Metabolic Abnormalities :
- Triglycerides >2.5× upper limit of normal (ULN) Cholesterol >2.5× ULN (method-dependent) Fasting whole-blood glucose >11.1 mmol/L Uric acid >2× ULN
- Pregnancy/Lactation : Currently pregnant, breastfeeding, or planning pregnancy within 3 months.
- Severe Organ Dysfunction : Advanced cardiovascular, hepatic, pulmonary, renal, or other critical organic diseases.
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- Thyroid Disorders : Diagnosed hyperthyroidism or hypothyroidism.
- Gastrointestinal Diseases : History of acute/chronic or active gastrointestinal disorders.
- Antibiotic Use : Oral/intravenous antibiotics within the past month.
- Psychiatric Disorders : Severe mental illness requiring routine psychiatric medication.
- Secondary Obesity : Hypothalamic obesity, Cushing's syndrome, hypogonadism-related obesity, etc.
- Specific Diets : Long-term vegan or restrictive dietary patterns.
- Weight Instability : ≥10% body weight change within the past 3 months.
- Compliance Concerns : Poor compliance or inability to adhere to the weight loss protocol (as judged by the investigator).
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jiayue Li, 010-69156874, pumchkyc@126.com
About this study
Official title: Study on the Weight Loss Effects and Mechanisms of Probiotic Preparation Intervention in Weight Cyclers: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- Study Background and Purpose Obesity is a complex chronic disease closely linked to comorbidities such as cardiovascular disease, hypertension, and diabetes. With lifestyle changes, obesity prevalence continues to rise. Current treatments focus on weight loss through dietary control and exercise, but weight regain is common due to metabolic adaptations (e.g., post-caloric restriction). Gut microbiota play a critical role in weight management, and probiotics may reduce weight regain by modulating appetite and metabolism. Studies suggest probiotics enhance satiety and reduce appetite. This study aims to evaluate the potential of probiotics in obesity management, specifically their impact on gut microbiota modulation and hormonal regulation to mitigate weight regain. Ethical approval has been obtained from the Peking Union Medical College Hospital Ethics Committee.
- Study Design This 198-participant, randomized, interventional trial will assign subjects to three groups (1:1:1 ratio): Placebo group (maltodextrin-based placebo) Probiotic Group 1 Probiotic Group 2 Randomization will be conducted via sealed envelopes (no researcher/participant bias). All groups receive standardized nutritional counseling, caloric restriction plans, and body composition assessments. Probiotics (produced by Shenzhen BaoShiJian Biotechnology Co., Ltd., compliant with standard Q/BSJ 0023S-2024) will be administered orally (2 bottles twice daily) for 84 days .
- Study Procedure Informed Consent : Required before participation. Screening Phase : Demographic history, medical records, concomitant medications, validated questionnaires, body composition analysis, and blood/urine/stool tests. Intervention : Daily probiotic or placebo intake for 84 days. Follow-ups : Visits at Day 42 and Day 85 for adherence checks, anthropometric measurements, and repeat testing.
- Study Completion Duration : 84 days. Post-Study : Placebo group receives 1-month free probiotic supply; others return to standard care. A 30-day post-study follow-up (phone/WeChat) will assess safety. Withdrawal : Participants may exit anytime. Investigators may withdraw participants for safety reasons.
- Potential Benefits Personalized nutrition counseling and body composition reports. Free clinical evaluations and health coaching. Contribution to novel weight management strategies for weight-cycling populations.
- Risks and Discomforts Adverse Events : Gastrointestinal symptoms or discomfort. Immediate reporting required for medical management.
Inconveniences :
Read more
3 on-site visits (blood/urine/stool tests, anthropometry) with fasting blood draws (~7-20 mL/session).
1 telehealth visit (25 min questionnaire). Daily diary cards. Compensation : 150 RMB travel reimbursement + study-provided scales. 7. Alternative Options
Participants may opt for:
Intermittent fasting. Pharmacotherapy (e.g., GLP-1 agonists). Standard dietary recommendations. 8. New Information Any significant findings during the trial will be communicated to participants, who may choose to continue or withdraw.
- Costs and Reimbursement No-cost : All investigational products (probiotics/placebo), lab tests, and body composition analyses.
Reimbursement : 150 RMB travel compensation + study tools (body fat scale, food scale, tape measure).
- Adverse Event Policy All injuries attributed to the intervention will be covered by Shenzhen BaoShiJian Biotechnology Co., Ltd. 's insurance. Legal liability extends beyond insurance coverage.
- Being tested
- WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100)., WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food., Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100).Dietary supplement
Also called Calorie-Restricted Diet
Product : WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100). Ingredients : Stachyose, fructooligosaccharides, isomaltooligosaccharides, maltodextrin, Lactiplantibacillus plantarum CECT7527, Lactiplantibacillus plantarum CECT7528, Lactiplantibacillus plantarum CECT7529, Lactobacillus acidophilus GOLDGUT-LA100, and Epigallocatechin gallate (EGCG).
Administration : Twice daily (2 bottles per dose) after meals for 12 weeks.
WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food.Dietary supplement
Also called Calorie-Restricted Diet
Product : WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food.
Ingredients :
S100 Components : As above. Weight Management Components : Isomaltooligosaccharides, fructooligosaccharides, maltodextrin, Lactobacillus fermentum K7-Lb1, Lactobacillus fermentum K8-Lb1, Lactobacillus fermentum K11-Lb3, Euglena gracilis, and phosphatidylserine.
Administration : Twice daily (2 bottles per dose) after meals for 12 weeks.
PlaceboDietary supplement
Also called Calorie-Restricted Diet
Daily oral administration of maltodextrin-based placebo (identical in taste, appearance, and packaging to probiotic products) twice daily (2 bottles per dose) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group 1 | Experimental | Daily oral administration of Probiotic Formulation 1 (2 bottles, twice daily) for 84 days. Receives: Dietary Supplement: WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100). |
| Probiotic Group 2 | Experimental | Daily oral administration of Probiotic Formulation 2 (2 bottles, twice daily) for 84 days. Receives: Dietary Supplement: WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food. |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with >5% Body Weight Loss
Proportion of participants achieving ≥5% reduction in body weight from baseline (D0) to end of intervention (D85).
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Secondary outcomes (10)
Change in Power of Food Scale (PFS) Score
The PFS assesses hedonic hunger on a 15-75 scale. Higher scores indicate greater responsiveness to the food environment.
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Fasting Insulin Concentration
Measured in fasting state using immunoassay.Unit of Measure: μU/mL
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Body Weight
Measured in kilograms using a calibrated digital scale.
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Triglyceride Concentration
Fasting triglycerides measured via enzymatic assay.Unit of Measure: mmol/L
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Gut Microbial α-Diversity (Shannon Index)
Microbial α-diversity will be assessed using the Shannon index. Higher values indicate greater microbial diversity.
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Number of Participants with Treatment-Related Adverse Events (AEs)
adverse events will be recorded and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Dutch Eating Behavior Questionnaire (DEBQ) Score
The DEBQ includes three subscales: emotional, external, and restrained eating. Each subscale is scored from 1 (low tendency) to 5 (high tendency). Higher scores indicate a stronger presence of the eating behavior.
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Fasting Ghrelin Concentration
Active ghrelin measured via ELISA.Unit of Measure: pg/mL
Measured: D0 to D85 ±7 days
Change in LDL-Cholesterol Concentration
LDL-C calculated using Friedewald formula or direct measurement.Unit of Measure: mmol/L
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Gastrointestinal Symptom Score
GI symptoms including bloating and diarrhea will be rated on a 5-point Likert scale (1 = none, 5 = very severe). Higher scores indicate more severe symptoms
Measured: From baseline (D0) to end of intervention (D85 ±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031596
- Sponsor's protocol ID
- K7816
- Acronym
- Probiotic
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Weight Loss Effects and Mechanisms of Probiotic Preparation Intervention in Weight Cyclers: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07031596
- Acronym / sponsor ID
- Probiotic / K7816
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jun 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.
- Study Background and Purpose Obesity is a complex chronic disease closely linked to comorbidities such as cardiovascular disease, hypertension, and diabetes. With lifestyle changes, obesity prevalence continues to rise. Current treatments focus on weight loss through dietary control and exercise, but weight regain is common due to metabolic adaptations (e.g., post-caloric restriction). Gut microbiota play a critical role in weight management, and probiotics may reduce weight regain by modulating appetite and metabolism. Studies suggest probiotics enhance satiety and reduce appetite. This study aims to evaluate the potential of probiotics in obesity management, specifically their impact on gut microbiota modulation and hormonal regulation to mitigate weight regain. Ethical approval has been obtained from the Peking Union Medical College Hospital Ethics Committee.
- Study Design This 198-participant, randomized, interventional trial will assign subjects to three groups (1:1:1 ratio): Placebo group (maltodextrin-based placebo) Probiotic Group 1 Probiotic Group 2 Randomization will be conducted via sealed envelopes (no researcher/participant bias). All groups receive standardized nutritional counseling, caloric restriction plans, and body composition assessments. Probiotics (produced by Shenzhen BaoShiJian Biotechnology Co., Ltd., compliant with standard Q/BSJ 0023S-2024) will be administered orally (2 bottles twice daily) for 84 days .
- Study Procedure Informed Consent : Required before participation. Screening Phase : Demographic history, medical records, concomitant medications, validated questionnaires, body composition analysis, and blood/urine/stool tests. Intervention : Daily probiotic or placebo intake for 84 days. Follow-ups : Visits at Day 42 and Day 85 for adherence checks, anthropometric measurements, and repeat testing.
- Study Completion Duration : 84 days. Post-Study : Placebo group receives 1-month free probiotic supply; others return to standard care. A 30-day post-study follow-up (phone/WeChat) will assess safety. Withdrawal : Participants may exit anytime. Investigators may withdraw participants for safety reasons.
- Potential Benefits Personalized nutrition counseling and body composition reports. Free clinical evaluations and health coaching. Contribution to novel weight management strategies for weight-cycling populations.
- Risks and Discomforts Adverse Events : Gastrointestinal symptoms or discomfort. Immediate reporting required for medical management.
Inconveniences :
3 on-site visits (blood/urine/stool tests, anthropometry) with fasting blood draws (~7-20 mL/session).
1 telehealth visit (25 min questionnaire). Daily diary cards. Compensation : 150 RMB travel reimbursement + study-provided scales. 7. Alternative Options
Participants may opt for:
Intermittent fasting. Pharmacotherapy (e.g., GLP-1 agonists). Standard dietary recommendations. 8. New Information Any significant findings during the trial will be communicated to participants, who may choose to continue or withdraw.
- Costs and Reimbursement No-cost : All investigational products (probiotics/placebo), lab tests, and body composition analyses.
Reimbursement : 150 RMB travel compensation + study tools (body fat scale, food scale, tape measure).
- Adverse Event Policy All injuries attributed to the intervention will be covered by Shenzhen BaoShiJian Biotechnology Co., Ltd. 's insurance. Legal liability extends beyond insurance coverage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group 1 | Experimental | Dietary Supplement: WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100).Daily oral administration of Probiotic Formulation 1 (2 bottles, twice daily) for 84 days. |
| Probiotic Group 2 | Experimental | Dietary Supplement: WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food.Daily oral administration of Probiotic Formulation 2 (2 bottles, twice daily) for 84 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Obesity : BMI ≥28 kg/m² and <35 kg/m².
- Weight Cycling History :
- Documented weight loss attempts within the past 2 years (≥3 episodes) with ≥5% body weight fluctuation.
- Age : 18-60 years (inclusive), male or female.
- Comprehension and Voluntariness : Ability to understand the weight loss protocol and willingness to complete the full study.
Key exclusion criteria (14 listed)
- Weight-Loss Medications : Current use of medications affecting weight (e.g., orlistat, GLP-1 receptor agonists, metformin).
- Diabetes Mellitus : Diagnosed diabetes or use of antidiabetic medications.
- Severe Metabolic Abnormalities :
- Triglycerides >2.5× upper limit of normal (ULN) Cholesterol >2.5× ULN (method-dependent) Fasting whole-blood glucose >11.1 mmol/L Uric acid >2× ULN
- Pregnancy/Lactation : Currently pregnant, breastfeeding, or planning pregnancy within 3 months.
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 |
|---|---|---|
| WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100).Also: Calorie-Restricted DietProduct : WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100). Ingredients : Stachyose, fructooligosaccharides, isomaltooligosaccharides, maltodextrin, Lactiplantibacillus plantarum CECT7527, Lactiplantibacillus plantarum CECT7528, Lactiplantibacillus plantarum CECT7529, Lactobacillus acidophilus GOLDGUT-LA100, and Epigallocatechin gallate (EGCG). Administration : Twice daily (2 bottles per dose) after meals for 12 weeks. | Dietary supplement | Probiotic Group 1 |
| WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food.Also: Calorie-Restricted DietProduct : WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food. Ingredients : S100 Components : As above. Weight Management Components : Isomaltooligosaccharides, fructooligosaccharides, maltodextrin, Lactobacillus fermentum K7-Lb1, Lactobacillus fermentum K8-Lb1, Lactobacillus fermentum K11-Lb3, Euglena gracilis, and phosphatidylserine. Administration : Twice daily (2 bottles per dose) after meals for 12 weeks. | Dietary supplement | Probiotic Group 2 |
| PlaceboAlso: Calorie-Restricted DietDaily oral administration of maltodextrin-based placebo (identical in taste, appearance, and packaging to probiotic products) twice daily (2 bottles per dose) for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Percentage of Participants with >5% Body Weight Loss
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Proportion of participants achieving ≥5% reduction in body weight from baseline (D0) to end of intervention (D85).
10 secondary outcomes
Change in Power of Food Scale (PFS) Score
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Fasting Insulin Concentration
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Body Weight
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Triglyceride Concentration
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Gut Microbial α-Diversity (Shannon Index)
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Number of Participants with Treatment-Related Adverse Events (AEs)
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Dutch Eating Behavior Questionnaire (DEBQ) Score
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Fasting Ghrelin Concentration
Time frame: D0 to D85 ±7 days
Change in LDL-Cholesterol Concentration
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
Change in Gastrointestinal Symptom Score
Time frame: From baseline (D0) to end of intervention (D85 ±7 days)
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 22 Jun 2025.
- Individual participant dataSharing planned: Yes
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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 study testing WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100). and WONDERLAB SHAPE100™ Ready-to-Eat Probiotic Food (S100) + WONDERLAB Weight Management Probiotic Food. in people with Obesity and Obesity-related Medical Conditions, run by Peking Union Medical College Hospital 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 6 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: opening soon, as of the sponsor's last update on 22 Jun 2025. 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. 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.
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 Na Yang, MD (86+13717712591, nayangchn@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with >5% Body Weight Loss (time frame: From baseline (D0) to end of intervention (D85 ±7 days)). 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 22 Jun 2025.