Overweight and ObesityNCT06213480
Next-Generation Synbiotic in Individuals With Overweight or Obesity
A study testing Synbiotic Group in people with Overweight and Obesity, run by Texas Christian University at 1 site in United States.
Trial summary
This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Synbiotic Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 20 May 2025
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- be between 18-50 years of age
- have a BMI between 25.0-40.0
Who cannot join
- are following a vegetarian, vegan, carnivore, or keto diet
- currently taking metformin, GLP-1 agonists, insulin, or fiber
- have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month
- pregnant, planning pregnancy during the study period, or lactating
- have a history of inflammatory bowel disease, colon cancer, or chronic polyps
- have been diagnosed with type 1 or type 2 diabetes
Show all 14Show fewer
- have active cancer
- are currently participating in a weight loss intervention (dietetic or medication)
- have used antibiotics, antifungals, or antivirals in the past 3 months
- have had a history of recent (within 30 days) diarrhea illness
- have a known allergy to any component of the study product
- have had an acute inflammatory infection or inflammatory condition in the past 4 weeks
- have had >10% weight variation in the past 6 months
- have had any bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Christian University, Rickel Building
Fort Worth, Texas, 76129
About this study
Official title: Supplementation With a Next-Generation Synbiotic in Individuals With Overweight or Obesity: A Triple-Blinded Randomized Controlled Clinical Trial
This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.
Read the detailed description
This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months.
Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups.
Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA.
Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c.
Body composition through DXA and BodPod will be measured before and after the symbiotic intervention.
Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.
- Conditions
- Overweight and Obesity
- Being tested
- Synbiotic Group, Placebo Group
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic GroupDietary supplement
Also called The utilized synbiotic is Pendulum Glucose Control
WBF-038: Noninfectious and nonhazardous lyophilized commensal bacteria (probiotics). Contains no genetically modified organisms (GMOs) and contains no animal ingredients or by-products, and were originally isolated from human sources. The (probiotic) strains are grown in a FDA registered food facility, adhering to Good Manufacturing Practice (GMP) conditions.
Probiotic Ingredients:
Clostridium butyricum WBSTR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WBSTR-0001, and Bifidobacterium infantis
The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation)
Placebo GroupOther
Also called Placebo
Ingredients: Chicory inulin and oligofructose (prebiotic fiber, hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation).
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic Group | Experimental | They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month symbiotic. The synbiotic that will be used in this trial contains the oligosaccharide-degrading probiotics, Akkermansia muciniphila and Bifidobacterium infantis; butyrate producers such as Clostridium beijerinckii, Anaerobutyricum hallii, and Clostridium butyricum; and chicory-derived inulin, a prebiotic dietary fiber. Receives: Dietary Supplement: Synbiotic Group |
| Placebo Group | Placebo comparator | They will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo. Receives: Other: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Fat Mass through DXA (percentage)
We will measure body fat mass by using DXA analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Total Body Fat Mass through BodPod (percentage)
We will measure body fat mass by using BodPod analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fat Mass to Height (kg/m2)
We will measure body fat mass by using DXA analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fat Mass (kg)
We will measure body fat mass by using BodPod analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Body Lean Mass to Height (kg/m2)
We will measure body lean mass by using DXA analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fat Free Mass (%)
We will measure body lean mass by using BodPod analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fat Free Mass (Kg)
We will measure body lean mass by using BodPod analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Visceral Fat Volume (cm3)
We will measure body visceral mass by using DXA and BodPod analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Visceral Fat Mass (grams)
We will measure body visceral mass by using DXA and BodPod analysis.
Measured: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
Fasting Glucose (mg/dL)
We will measure fasting glucose after a 12h fast.
Measured: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
Fasting Insulin (mIU/L)
We will measure fasting insulin after a 12h fast.
Measured: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
HbA1c (%)
We will measure HbA1c after a 12h fast.
Measured: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
Anxiety (number in 0-63 scale)
We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels.
Measured: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
Depression (number in 0-63 scale)
We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression.
Measured: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
Food cravings (number in 0-52 scale)
We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings.
Measured: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
Gut Microbial Composition (depending on funding availability at the time of analysis)
We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes.
Measured: Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
Blood Microbial Composition (depending on funding availability at the time of analysis)
We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes.
Measured: Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
Body Weight (kg)
Body weight will be measured with a calibrated scale.
Measured: Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
Body Height (meters)
Body height will be measured with a stadiometer.
Measured: Measurement will take place at the first visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start2 Feb 2024
- Primary completion20 May 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty participants will be randomized into one of two groups: 1) 3-day antibiotic plus placebo for 3 months, or 2) 3-day antibiotic plus symbiotic for 3 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- Pendulum Therapeutics
- Responsible party
- Principal investigator, Elisa Marroquin, Texas Christian University
- Investigators
- Elisa Marroquin, Ph.D., Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213480
- Sponsor's protocol ID
- 2023-345
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data can be shared only after authors and co-authors have published the material of their interest.
Publications
Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.
PubMed 31263284Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.
PubMed 32675291
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation With a Next-Generation Synbiotic in Individuals With Overweight or Obesity: A Triple-Blinded Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06213480
- Acronym / sponsor ID
- 2023-345
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Collaborators
- Pendulum Therapeutics
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.
Detailed description
This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months.
Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups.
Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA.
Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c.
Body composition through DXA and BodPod will be measured before and after the symbiotic intervention.
Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sixty participants will be randomized into one of two groups: 1) 3-day antibiotic plus placebo for 3 months, or 2) 3-day antibiotic plus symbiotic for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Group | Experimental | Dietary Supplement: Synbiotic GroupThey will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month symbiotic. The synbiotic that will be used in this trial contains the oligosaccharide-degrading probiotics, Akkermansia muciniphila and Bifidobacterium infantis; butyrate producers such as Clostridium beijerinckii, Anaerobutyricum hallii, and Clostridium butyricum; and chicory-derived inulin, a prebiotic dietary fiber. |
| Placebo Group | Placebo comparator | Other: Placebo GroupThey will receive a 3-day antibiotic (Vancomycin 500 mg/3 times/day), followed by a 3-month placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- be between 18-50 years of age
- have a BMI between 25.0-40.0
Key exclusion criteria (14 listed)
- are following a vegetarian, vegan, carnivore, or keto diet
- currently taking metformin, GLP-1 agonists, insulin, or fiber
- have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month
- pregnant, planning pregnancy during the study period, or lactating
- have a history of inflammatory bowel disease, colon cancer, or chronic polyps
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 |
|---|---|---|
| Synbiotic GroupAlso: The utilized synbiotic is Pendulum Glucose ControlWBF-038: Noninfectious and nonhazardous lyophilized commensal bacteria (probiotics). Contains no genetically modified organisms (GMOs) and contains no animal ingredients or by-products, and were originally isolated from human sources. The (probiotic) strains are grown in a FDA registered food facility, adhering to Good Manufacturing Practice (GMP) conditions. Probiotic Ingredients: Clostridium butyricum WBSTR-0006, Clostridium beijerinckii WB-STR-0005, Anaerobutyricum hallii WB-STR-0008, Akkermansia muciniphila WBSTR-0001, and Bifidobacterium infantis The product also contains: Chicory inulin and oligofructose (prebiotic fiber), hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation) | Dietary supplement | Synbiotic Group |
| Placebo GroupAlso: PlaceboIngredients: Chicory inulin and oligofructose (prebiotic fiber, hypromellose (vegetarian capsule), fruit \& vegetable juice (coloring agent), magnesium stearate and silica (flow agent for encapsulation). | Other | Placebo Group |
Primary outcome
Total Body Fat Mass through DXA (percentage)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body fat mass by using DXA analysis.
Total Body Fat Mass through BodPod (percentage)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body fat mass by using BodPod analysis.
Fat Mass to Height (kg/m2)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body fat mass by using DXA analysis.
Fat Mass (kg)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body fat mass by using BodPod analysis.
Body Lean Mass to Height (kg/m2)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body lean mass by using DXA analysis.
Fat Free Mass (%)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body lean mass by using BodPod analysis.
Fat Free Mass (Kg)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body lean mass by using BodPod analysis.
Visceral Fat Volume (cm3)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body visceral mass by using DXA and BodPod analysis.
Visceral Fat Mass (grams)
Time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.
We will measure body visceral mass by using DXA and BodPod analysis.
Fasting Glucose (mg/dL)
Time frame: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
We will measure fasting glucose after a 12h fast.
Fasting Insulin (mIU/L)
Time frame: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
We will measure fasting insulin after a 12h fast.
HbA1c (%)
Time frame: Blood samples will be taken before the antibiotic, before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
We will measure HbA1c after a 12h fast.
Anxiety (number in 0-63 scale)
Time frame: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
We will measure anxiety by using the Beck Anxiety inventory. The higher the number, the higher the anxiety levels.
Depression (number in 0-63 scale)
Time frame: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
We will measure depression by using the Beck Depression inventory. The higher the number, the higher the depression.
Food cravings (number in 0-52 scale)
Time frame: These questionnaires will be applied right before and right after the 3-month synbiotic/placebo intervention.
We will measure food cravings by using the Reward-based Eating Drive questionnaire (RED-9). The higher the number, the higher the cravings.
Gut Microbial Composition (depending on funding availability at the time of analysis)
Time frame: Stool samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
We plan to measure gut microbial composition by performing whole metagenome sequencing previously stored in Zymo stool collection tubes.
Blood Microbial Composition (depending on funding availability at the time of analysis)
Time frame: Blood samples will be collected right before the antibiotic, right before the synbiotic/placebo intervention, and right after the 3-month synbiotic/placebo intervention.
We plan to measure blood microbial composition by performing 16S rRNA in blood samples previously stored in Zymo blood collection tubes.
Body Weight (kg)
Time frame: Measurements will take place at each of the 3 visits: right before the antibiotic, right before the synbiotic/placebo, and right after the 3-month synbiotic/placebo intervention.
Body weight will be measured with a calibrated scale.
Body Height (meters)
Time frame: Measurement will take place at the first visit.
Body height will be measured with a stadiometer.
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 2 Oct 2026.
- Background: PubMed 31263284Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.
- Background: PubMed 32675291Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.
- Individual participant dataSharing planned: Yes. De-identified participant-level data can be shared only after authors and co-authors have published the material of their interest.
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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.
Elisa Marroquin, Ph.D. principal investigator
Texas Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic Group in people with Overweight and Obesity, run by Texas Christian University at 1 site in United States.
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 2 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 2 Oct 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 United States. 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?
Total Body Fat Mass through DXA (percentage) (time frame: These analyses will take place right before and right after the 3-month synbiotic/placebo intervention.). The study lists 19 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 NCT06213480, which also lists 2 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 2 Oct 2026.