Overweight and ObesityNCT06030999

The Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

A study testing Study product A (Wonderlab wonder4shape) and Study product B (Wonderlab wonder4shape) in people with Overweight and Obesity, run by Shenzhen Precision Health Food Technology Co. Ltd., at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this interventional study is to test whether consumption of Wonderlab probiotics with prebiotics could improve obesity and overweight in Chinese people who are aged 25-45 and overweight. Read more about this study

Who is it for?: Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity
What is being tested?: Study product A (Wonderlab wonder4shape) and Study product B (Wonderlab wonder4shape)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 2 sitesChina
Study dates: 18 Sep 2023to 15 Dec 2023
Phase: Interventional
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 25 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Chinese males or females, age between 25-45;
Overweight population: BMI 24-27.9 \& obesity population: BMI >=28;
Blood lipids in high potential risks but without medication:TG > 5mmol/L or LDL >= 3.4 mmol/L or TC >= 5.2 mmol/L.
Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
Agree to avoid medication treatment for weight management, including blood lipids and sugar control.

Who cannot join

Have used any medication for weight management at least one month before this study.
Subject having done plastic surgery for weight management.
Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease.
Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study.

Show all 10Show fewer

Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, pregnancy, lactation and hepatitis.
Have any cuts/abrasions on the test site at baseline.
The subject is an employee of sponsor or the site conducting the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Ligang Hospital
Jinhua, Zhejiang
SPRIM Central Lab
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics

whether the weight of participants can be lost after 10 weeks' intervention

150 participants will be randomized into 3 study groups (50 each group) in the two study sites, who will consume assigned product according to instructions for 10 weeks. Three site visits will be made for each participant and all relevant clinical data will be captured and recorded into CTMS(Clinical Trial Management System) for statistical analysis.

Researchers will compare the three groups to conclude whether the Wonderlab study product can improve obesity and overweight over placebo product.

Conditions: Overweight and Obesity
Being tested: Study product A (Wonderlab wonder4shape), Study product B (Wonderlab wonder4shape), Study product C (placebo)
Keywords: Probiotics, Prebiotics, Wonderlab
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study product A (Wonderlab wonder4shape)Dietary supplement
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
Study product B (Wonderlab wonder4shape)Dietary supplement
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks
Study product C (placebo)Dietary supplement
Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks

Study groups in NCT06030999
Study group	Role	What they receive
Study product A (Wonderlab wonder4shape)	Active comparator	2g/bottle, containing the following probiotics total dosage 2.01010 CFU: CECT7527, CECT7528, CECT7529 * Maltodextrin * Lactobacillus acidophilus * Fructose oligosaccharides * Grapefruit, Lemon and Apple powder Receives: Dietary Supplement: Study product A (Wonderlab wonder4shape)
Study product B (Wonderlab wonder4shape)	Active comparator	2g/bottle, containing the following probiotics total dosage 1.01010 CFU: Maltodextrin * Lactobacillus acidophilus Receives: Dietary Supplement: Study product B (Wonderlab wonder4shape)
Study product C (placebo)	Placebo comparator	2g/bottle, containing the following ingredients: * Maltodextrin * Grapefruit powder * Lemon powder Receives: Dietary Supplement: Study product C (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Weight
Change of Weight in Kg by Inbody S10 from baseline to 10 weeks
Measured: baseline day 0, day 70

Secondary outcomes (5)

Blood lipids - Total Cholesterol Level
Blood lipids - Total Cholesterol level of blood test in mmol/L and range of 0.56-17mmol/L for each visit interval
Measured: baseline day 0, day 35, day 70
Blood Sugar Level
Blood sugar level of blood test in mmol/L and range of 3.9-6.1mmol/L
Measured: baseline day 0, day 35, day 70
Blood hormone - Leptin level
Blood hormone - Leptin level of blood test in ng/mL and range 0.5-15.2ng/mL
Measured: baseline day 0, day 35, day 70
Blood hormone - Adiponectin level
Blood hormone - Adiponectin level of blood test in ug/mL and range of 2-37ug/mL
Measured: baseline day 0, day 35, day 70
Blood inflammation
Blood inflammation (Zonulin, ApoB-48, hsCRP, LPS, sCD14, IL-6, MCP-1, Angptl4)
Measured: baseline day 0, day 35, day 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 202315 Dec 2023

First posted11 Sep 2023
Study start18 Sep 2023
Primary completion2 Dec 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Overweight and ObesityStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06030999
Sponsor's protocol ID: 23-SM-08-WL-001
Status last verified: Feb 2024
First submitted: 3 Sep 2023
Last updated: 21 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Aoun A, Darwish F, Hamod N. The Influence of the Gut Microbiome on Obesity in Adults and the Role of Probiotics, Prebiotics, and Synbiotics for Weight Loss. Prev Nutr Food Sci. 2020 Jun 30;25(2):113-123. doi: 10.3746/pnf.2020.25.2.113.
PubMed 32676461
Guirro M, Costa A, Gual-Grau A, Herrero P, Torrell H, Canela N, Arola L. Effects from diet-induced gut microbiota dysbiosis and obesity can be ameliorated by fecal microbiota transplantation: A multiomics approach. PLoS One. 2019 Sep 23;14(9):e0218143. doi: 10.1371/journal.pone.0218143. eCollection 2019.
PubMed 31545802
Gill VJS, Soni S, Shringarpure M, Anusheel, Bhardwaj S, Yadav NK, Patel A, Patel A. Gut Microbiota Interventions for the Management of Obesity: A Literature Review. Cureus. 2022 Sep 19;14(9):e29317. doi: 10.7759/cureus.29317. eCollection 2022 Sep.
PubMed 36161997
Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.
PubMed 24912386
Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
PubMed 28611480
Swanson KS, Gibson GR, Hutkins R, Reimer RA, Reid G, Verbeke K, Scott KP, Holscher HD, Azad MB, Delzenne NM, Sanders ME. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of synbiotics. Nat Rev Gastroenterol Hepatol. 2020 Nov;17(11):687-701. doi: 10.1038/s41575-020-0344-2. Epub 2020 Aug 21.
PubMed 32826966
Arora T, Sharma R. Fermentation potential of the gut microbiome: implications for energy homeostasis and weight management. Nutr Rev. 2011 Feb;69(2):99-106. doi: 10.1111/j.1753-4887.2010.00365.x.
PubMed 21294743
Lee HY, Park JH, Seok SH, Baek MW, Kim DJ, Lee KE, Paek KS, Lee Y, Park JH. Human originated bacteria, Lactobacillus rhamnosus PL60, produce conjugated linoleic acid and show anti-obesity effects in diet-induced obese mice. Biochim Biophys Acta. 2006 Jul;1761(7):736-44. doi: 10.1016/j.bbalip.2006.05.007. Epub 2006 May 20.
PubMed 16807088
Martin FP, Wang Y, Sprenger N, Yap IK, Lundstedt T, Lek P, Rezzi S, Ramadan Z, van Bladeren P, Fay LB, Kochhar S, Lindon JC, Holmes E, Nicholson JK. Probiotic modulation of symbiotic gut microbial-host metabolic interactions in a humanized microbiome mouse model. Mol Syst Biol. 2008;4:157. doi: 10.1038/msb4100190. Epub 2008 Jan 15.
PubMed 18197175
Guazzelli Marques C, de Piano Ganen A, Zaccaro de Barros A, Thomatieli Dos Santos RV, Dos Santos Quaresma MVL. Weight loss probiotic supplementation effect in overweight and obesity subjects: A review. Clin Nutr. 2020 Mar;39(3):694-704. doi: 10.1016/j.clnu.2019.03.034. Epub 2019 Apr 3.
PubMed 30987812
Bosch M, Fuentes MC, Audivert S, Bonachera MA, Peiro S, Cune J. Lactobacillus plantarum CECT 7527, 7528 and 7529: probiotic candidates to reduce cholesterol levels. J Sci Food Agric. 2014 Mar 15;94(4):803-9. doi: 10.1002/jsfa.6467. Epub 2013 Dec 4.
PubMed 24186773
Kim GB, Yi SH, Lee BH. Purification and characterization of three different types of bile salt hydrolases from Bifidobacterium strains. J Dairy Sci. 2004 Feb;87(2):258-66. doi: 10.3168/jds.S0022-0302(04)73164-1.
PubMed 14762068
Begley M, Hill C, Gahan CG. Bile salt hydrolase activity in probiotics. Appl Environ Microbiol. 2006 Mar;72(3):1729-38. doi: 10.1128/AEM.72.3.1729-1738.2006. No abstract available.
PubMed 16517616
Verhoog S, Taneri PE, Roa Diaz ZM, Marques-Vidal P, Troup JP, Bally L, Franco OH, Glisic M, Muka T. Dietary Factors and Modulation of Bacteria Strains of Akkermansia muciniphila and Faecalibacterium prausnitzii: A Systematic Review. Nutrients. 2019 Jul 11;11(7):1565. doi: 10.3390/nu11071565.
PubMed 31336737
Hills RD Jr, Pontefract BA, Mishcon HR, Black CA, Sutton SC, Theberge CR. Gut Microbiome: Profound Implications for Diet and Disease. Nutrients. 2019 Jul 16;11(7):1613. doi: 10.3390/nu11071613.
PubMed 31315227

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Three Arms, Randomized, Double-blind Controlled Trial Of Prevention And Treatment On Obesity And Weight Management By Oral Supplementation Of Probiotics And Prebiotics
ClinicalTrials.gov ID: NCT06030999
Acronym / sponsor ID: 23-SM-08-WL-001
Conditions: Overweight and Obesity
Keywords: Probiotics, Prebiotics, Wonderlab
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,Other government
Study start: 18 Sep 2023 (actual)
Primary completion: 2 Dec 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 11 Sep 2023 (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.

whether the weight of participants can be lost after 10 weeks' intervention

Researchers will compare the three groups to conclude whether the Wonderlab study product can improve obesity and overweight over placebo product.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Study product A (Wonderlab wonder4shape)	Active comparator	Dietary Supplement: Study product A (Wonderlab wonder4shape)2g/bottle, containing the following probiotics total dosage 2.01010 CFU: CECT7527, CECT7528, CECT7529 * Maltodextrin * Lactobacillus acidophilus * Fructose oligosaccharides * Grapefruit, Lemon and Apple powder
Study product B (Wonderlab wonder4shape)	Active comparator	Dietary Supplement: Study product B (Wonderlab wonder4shape)2g/bottle, containing the following probiotics total dosage 1.01010 CFU: Maltodextrin * Lactobacillus acidophilus
Study product C (placebo)	Placebo comparator	Dietary Supplement: Study product C (placebo)2g/bottle, containing the following ingredients: * Maltodextrin * Grapefruit powder * Lemon powder

Who may qualify

Ages: 25 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Chinese males or females, age between 25-45;
Overweight population: BMI 24-27.9 \& obesity population: BMI >=28;
Blood lipids in high potential risks but without medication:TG > 5mmol/L or LDL >= 3.4 mmol/L or TC >= 5.2 mmol/L.
Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
Agree to avoid medication treatment for weight management, including blood lipids and sugar control.

Key exclusion criteria (10 listed)

Have used any medication for weight management at least one month before this study.
Subject having done plastic surgery for weight management.
Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease.

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
Study product A (Wonderlab wonder4shape)Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks	Dietary supplement	Study product A (Wonderlab wonder4shape)
Study product B (Wonderlab wonder4shape)Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks	Dietary supplement	Study product B (Wonderlab wonder4shape)
Study product C (placebo)Participants in this arm need to consume one bottle (2g) of this product once a day for 10 weeks	Dietary supplement	Study product C (placebo)

Primary outcome

Change of Weight
Time frame: baseline day 0, day 70
Change of Weight in Kg by Inbody S10 from baseline to 10 weeks

5 secondary outcomes

Blood lipids - Total Cholesterol Level
Time frame: baseline day 0, day 35, day 70
Blood Sugar Level
Time frame: baseline day 0, day 35, day 70
Blood hormone - Leptin level
Time frame: baseline day 0, day 35, day 70
Blood hormone - Adiponectin level
Time frame: baseline day 0, day 35, day 70
Blood inflammation
Time frame: baseline day 0, day 35, day 70

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 21 Feb 2024.
Background: PubMed 32676461Aoun A, Darwish F, Hamod N. The Influence of the Gut Microbiome on Obesity in Adults and the Role of Probiotics, Prebiotics, and Synbiotics for Weight Loss. Prev Nutr Food Sci. 2020 Jun 30;25(2):113-123. doi: 10.3746/pnf.2020.25.2.113.
Background: PubMed 31545802Guirro M, Costa A, Gual-Grau A, Herrero P, Torrell H, Canela N, Arola L. Effects from diet-induced gut microbiota dysbiosis and obesity can be ameliorated by fecal microbiota transplantation: A multiomics approach. PLoS One. 2019 Sep 23;14(9):e0218143. doi: 10.1371/journal.pone.0218143. eCollection 2019.
Background: PubMed 36161997Gill VJS, Soni S, Shringarpure M, Anusheel, Bhardwaj S, Yadav NK, Patel A, Patel A. Gut Microbiota Interventions for the Management of Obesity: A Literature Review. Cureus. 2022 Sep 19;14(9):e29317. doi: 10.7759/cureus.29317. eCollection 2022 Sep.
Background: PubMed 24912386Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.
Background: PubMed 28611480Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
Background: PubMed 32826966Swanson KS, Gibson GR, Hutkins R, Reimer RA, Reid G, Verbeke K, Scott KP, Holscher HD, Azad MB, Delzenne NM, Sanders ME. The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of synbiotics. Nat Rev Gastroenterol Hepatol. 2020 Nov;17(11):687-701. doi: 10.1038/s41575-020-0344-2. Epub 2020 Aug 21.
Background: PubMed 21294743Arora T, Sharma R. Fermentation potential of the gut microbiome: implications for energy homeostasis and weight management. Nutr Rev. 2011 Feb;69(2):99-106. doi: 10.1111/j.1753-4887.2010.00365.x.
Background: PubMed 16807088Lee HY, Park JH, Seok SH, Baek MW, Kim DJ, Lee KE, Paek KS, Lee Y, Park JH. Human originated bacteria, Lactobacillus rhamnosus PL60, produce conjugated linoleic acid and show anti-obesity effects in diet-induced obese mice. Biochim Biophys Acta. 2006 Jul;1761(7):736-44. doi: 10.1016/j.bbalip.2006.05.007. Epub 2006 May 20.
Background: PubMed 18197175Martin FP, Wang Y, Sprenger N, Yap IK, Lundstedt T, Lek P, Rezzi S, Ramadan Z, van Bladeren P, Fay LB, Kochhar S, Lindon JC, Holmes E, Nicholson JK. Probiotic modulation of symbiotic gut microbial-host metabolic interactions in a humanized microbiome mouse model. Mol Syst Biol. 2008;4:157. doi: 10.1038/msb4100190. Epub 2008 Jan 15.
Background: PubMed 30987812Guazzelli Marques C, de Piano Ganen A, Zaccaro de Barros A, Thomatieli Dos Santos RV, Dos Santos Quaresma MVL. Weight loss probiotic supplementation effect in overweight and obesity subjects: A review. Clin Nutr. 2020 Mar;39(3):694-704. doi: 10.1016/j.clnu.2019.03.034. Epub 2019 Apr 3.
Background: PubMed 24186773Bosch M, Fuentes MC, Audivert S, Bonachera MA, Peiro S, Cune J. Lactobacillus plantarum CECT 7527, 7528 and 7529: probiotic candidates to reduce cholesterol levels. J Sci Food Agric. 2014 Mar 15;94(4):803-9. doi: 10.1002/jsfa.6467. Epub 2013 Dec 4.
Background: PubMed 14762068Kim GB, Yi SH, Lee BH. Purification and characterization of three different types of bile salt hydrolases from Bifidobacterium strains. J Dairy Sci. 2004 Feb;87(2):258-66. doi: 10.3168/jds.S0022-0302(04)73164-1.
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. This study is not recruiting at the moment.

Hongwei Guo, MD principal investigator

Shanghai Fudan University, School of Public Health

Weixing Wang, MD principal investigator

Shanghai Jiao Tong University School of Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 10 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Change of Weight (time frame: baseline day 0, day 70). 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 NCT06030999, which also lists 15 linked publications.

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 21 Feb 2024.