Knee ProsthesisMILESTONENCT06944288
Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination
A study testing total knee replacement in people with Knee Prosthesis and Knee Prosthesis Infection, run by Istituto Clinico Humanitas.
Trial summary
The patient(s) will participate in a clinical study that aims to investigate how the gut microbiota may influence the proper functioning of joints in the body and how it may affect the development of early osteoarthritis (OA), periprosthetic joint infection (PJI), and recovery after total joint replacement. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Knee Prosthesis, Knee Prosthesis Infection, Disbiosis
- What is being tested?
- total knee replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 30 May 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- proven gut dysbiosis (increased Firmicutes/Bacteroidetes (F/B) phyla ratio and increased permeability); age range 18-50 years old.
- patients undergoing total knee replacement surgery
- patients undergoing joint revision surgery for septic failure of a knee or hip prostheses; patients undergoing revision surgery for aseptic mobilization for PJI
Who cannot join
- musculoskeletal symptoms; previous shoulder or knee surgery; previous shoulder or knee known pathological conditions; rheumatological diseases
- any concurrent or previous diseases or conditions which might negatively affect the surgery
- major predisposing factor for gut dysbiosis (antibiotic therapy in the last 6 months, BMI > 40 and inflammatory bowel disease); chronic inflammatory joint diseases (e.g., rheumatoid arthritis, psoriatic arthritis); acute (< 90 days after the index procedure) and late hematogenous (symptoms of less than three weeks duration) infections; an inadequate amount of synovial fluid (< 10 mL) for culture, WBC, and PMN (neutrophil) percentage determinations
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination (MILESTONE)
The patient(s) will participate in a clinical study that aims to investigate how the gut microbiota may influence the proper functioning of joints in the body and how it may affect the development of early osteoarthritis (OA), periprosthetic joint infection (PJI), and recovery after total joint replacement.
In particular, the prevalence of early OA among patients with gut dysbiosis will be studied (Objective 1). The aim is to identify gut dysbiosis as a potential diagnostic factor for early OA. The study will analyze knee MRI scans and shoulder ultrasound images of 40 patients without musculoskeletal symptoms but with confirmed gut dysbiosis.In addition, the intra-articular microbiota in 50 patients undergoing total knee replacement will be investigated. Serum LPS levels during surgery and fecal microbiota before surgery and during postoperative recovery will be assessed (Objective 2). Postoperative recovery will be assessed based on criteria such as time off crutches and subjective scores.
Read more
Finally, this will explore the correlation between gut microbiota and contaminating germs in periprosthetic infections. (Objective 3). 40 patients undergoing joint revision surgery for septic failure of a knee or hip replacement and 40 patients undergoing revision surgery for aseptic loosening for PJI will undergo gut microbiota analysis. Comparison between the two groups will allow evaluation of whether PJI causes changes in the gut microbiota.
The patients will be included in the study under
- objective 1
- objective 2
- objective 3
Read the detailed description
The study is a multicentre observational study divided into 3 objectives:
Objective #1 is to enrol 40 patients with established intestinal dysbiosis and no musculoskeletal symptoms. Patients with potential dysbiosis will undergo an initial (V1) gastroenterological examination at the Operative Unit of Gastroenterology and Digestive Endoscopy in Humanitas, where they will be asked to join the clinical study. Each patient will be explained the study through the means of the informed consent process, and those who wish to join the study will sign the informed consent form. For each patient, the Bristol scale will be used as a tool to categorize the patients' stool as reported by the patient; a stool sample collection kit will be provided to the patient together with its instructions for use. Patients will be instructed to provide a stool sample (V2) at the immunology and microbiota unit laboratory. On the same occasion, the clinician will perform a buccal swab to collect a saliva sample from the patient (see section 8 for specifics). Both samples will initially be stored at the Biobank - Cancer Center (Istituto Clinico Humanitas - Via Manzoni 56, 20089 Rozzano (MI)) under the responsibility of Dr. Daniela Pistillo and will then be processed at the laboratory of the immunology and microbiota unit and will be used for confirming the dysbiosis diagnosis. If the patient is not positive for dysbiosis markers, he/she will be classified as SCREENING FAILURE; if the dysbiosis is confirmed, the patient will be asked to come to another visit (V3) where he/she will undergo a MRI of the knee and a shoulder ultrasound scan in order to check for early osteoarthritis signs. Optional orthopaedic examination may be performed. Blood test will also be performed part of the samples of which will be used to evaluate biomarkers and will initially be stored at the Biobank - Cancer Center (Istituto Clinico Humanitas - Via Manzoni 56, 20089 Rozzano (MI)) with Dr. Daniela Pistillo in charge and will subsequently be processed. The other part of the blood samples on which insulin, glycated haemoglobin and glucose will be analysed will be sent to the Central Analysis Laboratory within ICH (see section 8 for details).
Objective #2 is to enrol 50 patients undergoing total knee arthroplasty (TKA). Patients scheduled to undergo TKA will undergo a pre-hospitalization orthopaedic examination (V1) where he/she will be informed about the clinical study. If he/she agrees to join the study, he/she will sign the informed consent form and will follow study procedures: questionnaires will be administered and the patient will receive a stool sample collection kit together with its instructions for use. The stool sample will be used for DNA extraction at the immunology and microbiota unit laboratory and subsequent metagenomic analysis. Patient will be instructed to hand over the stool sample during hospital visit for TKA (V2), during which intra-articular tissue samples will be collected for metagenomics. In addition, buccal swab and blood samples of the patient undergoing the surgery will be collected before surgery. Saliva, stool and blood samples for biomarkers will initially be stored at the Biobank - Cancer Center (Istituto Clinico Humanitas - Via Manzoni 56, 20089 Rozzano (MI)) under the responsibility of Dr. Daniela Pistillo and will subsequently be processed at the laboratory of the immunology and microbiota unit. The other part of the blood samples on which insulin, glycated haemoglobin and glucose will be analysed will be sent to the ICH's in-house Central Analysis Laboratory. On discharge, patient will be provided another stool collection kit. One month after surgery (V3), a follow-up examination will be performed, where patient will bring the second stool sample and will undergo another buccal swab which will also be analysed by the same laboratory (see section 8). For stool and saliva samples of V3, the storage and analysis procedure is the same as for V2. In addition, the patient will fill in the KSS questionnaires.
Objective #3 involves the enrolment of 80 patients undergoing joint revision surgery who are further divided into:
Group 1: 40 patients for septic failure of a knee or hip replacement. Group 2: 40 patients for aseptic loosening for PJI Patients will undergo a pre-hospitalization visit (V1) with orthopaedic check-up, where they will be asked to join the clinical study. Each patient will be explained the study through the means of the informed consent process, and those who wish to join the study will sign the informed consent form. Patient will be provided a stool sample collection kit for DNA extraction at the immunology and microbiota unit laboratory and subsequent metagenomic analysis. The patient will be instructed to hand over the stool sample during hospital visit for revision surgery (V2) (see section 8).
- Conditions
- Knee Prosthesis, Knee Prosthesis Infection, Disbiosis
- Being tested
- total knee replacement
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee replacementProcedure or surgery
The Orthopedic Surgeon will remove the damaged cartilage and bone then implant the new metal and plastic knee to restore the alignment and function of your knee. The surgical procedure takes about 1-2 hours on average. While in case of infection, an antibiotic cement is inserted, which will be removed with the subsequent prosthetic implant surgery. Finally, prosthetic components can be more filling, depending on the amount of bone that is previously removed.
| Study group | Role | What they receive |
|---|---|---|
| SURGERY | Other | TOTAL KNEE REPLACEMENT SURGERY AND REVISION SURGERY OF INFECTED KNEE PROSTHESIS Receives: Procedure: total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome 1 : to identify gut dysbiosis as a potential diagnostic tool for early OA.
The study aims to establish gut dysbiosis as a potential diagnostic tool for early OA. If a strong association between gut dysbiosis and early OA is found, it could contribute to the development of a diagnostic protocol for early OA. The identification of gut dysbiosis as an early marker of OA could represent an additional diagnostic tool, allowing for early intervention and prevention of further progression of the disease. Early recognition of OA would allow a precocious and timely intervention which could positibely alter the natural history of this condition.
Measured: 1 year
Outcome 2: to investigate the intraarticular microbiota, serum LPS levels during surgery, and fecal microbiota before surgery and during recovery.
The analysis may reveal specific microbial imbalances or dysregulated pathways in the gut microbiota and serum LPS levels that are correlated with post-operative recovery outcomes. The study seeks to determine whether there is a correlation between the gut microbiota composition and post-operative recovery after total kneereplacement (TKA). It is expected that certain microbial taxa or functional pathways i n the gut microbiota will be associated with faster recovery, as indicated by shorter time taken to abandon crutches and higher subjective scores (e.g., KneeSociety Score, KSS score). The study aims to investigate the role of the gut microbiota as a predicting factor for joint arthroplasty recovery. If a significant correlation is found between specific microbial imbalances or dysregulated pathways and post-operative recovery outcomes, it could indicate that the gut microbiota can serve as a predictive factor for recoveryafter TKA.
Measured: 1 year
Outcome 3: to investigate if periprosthetic joint infections (PJI) influences gut microbiota environment predisposing to gut dysbiosis, which negatively affects life expectancy in these patients.
The analysis may reveal specific microbial imbalances or dysregulated pathways in the gut microbiota that are correlated with the presence of PJI. It is expected that patients with PJI will exhibit distinct alterations in the gut microbiota compared to patients undergoing revision surgery for aseptic mobilization. The analysis may establish a correlation between specific microbial taxa or functional pathways in the gut microbiota and the occurrence of PJI.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ProsthesisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prosthesis surgery Revision of infected prosthesis
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
- Responsible party
- Sponsor
- Investigators
- TOMMASO BONANZINGA, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944288
- Sponsor's protocol ID
- PNRR-MCNT2-2023-12377976
- Acronym
- MILESTONE
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 25 Apr 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination (MILESTONE)
- ClinicalTrials.gov ID
- NCT06944288
- Acronym / sponsor ID
- MILESTONE / PNRR-MCNT2-2023-12377976
- Conditions
- Knee Prosthesis, Knee Prosthesis Infection, Disbiosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 25 Apr 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 patient(s) will participate in a clinical study that aims to investigate how the gut microbiota may influence the proper functioning of joints in the body and how it may affect the development of early osteoarthritis (OA), periprosthetic joint infection (PJI), and recovery after total joint replacement.
In particular, the prevalence of early OA among patients with gut dysbiosis will be studied (Objective 1). The aim is to identify gut dysbiosis as a potential diagnostic factor for early OA. The study will analyze knee MRI scans and shoulder ultrasound images of 40 patients without musculoskeletal symptoms but with confirmed gut dysbiosis.In addition, the intra-articular microbiota in 50 patients undergoing total knee replacement will be investigated. Serum LPS levels during surgery and fecal microbiota before surgery and during postoperative recovery will be assessed (Objective 2). Postoperative recovery will be assessed based on criteria such as time off crutches and subjective scores.
Finally, this will explore the correlation between gut microbiota and contaminating germs in periprosthetic infections. (Objective 3). 40 patients undergoing joint revision surgery for septic failure of a knee or hip replacement and 40 patients undergoing revision surgery for aseptic loosening for PJI will undergo gut microbiota analysis. Comparison between the two groups will allow evaluation of whether PJI causes changes in the gut microbiota.
The patients will be included in the study under
- objective 1
- objective 2
- objective 3
Detailed description
The study is a multicentre observational study divided into 3 objectives:
Objective #1 is to enrol 40 patients with established intestinal dysbiosis and no musculoskeletal symptoms. Patients with potential dysbiosis will undergo an initial (V1) gastroenterological examination at the Operative Unit of Gastroenterology and Digestive Endoscopy in Humanitas, where they will be asked to join the clinical study. Each patient will be explained the study through the means of the informed consent process, and those who wish to join the study will sign the informed consent form. For each patient, the Bristol scale will be used as a tool to categorize the patients' stool as reported by the patient; a stool sample collection kit will be provided to the patient together with its instructions for use. Patients will be instructed to provide a stool sample (V2) at the immunology and microbiota unit laboratory. On the same occasion, the clinician will perform a buccal swab to collect a saliva sample from the patient (see section 8 for specifics). Both samples will initially be stored at the Biobank - Cancer Center (Istituto Clinico Humanitas - Via Manzoni 56, 20089 Rozzano (MI)) under the responsibility of Dr. Daniela Pistillo and will then be processed at the laboratory of the immunology and microbiota unit and will be used for confirming the dysbiosis diagnosis. If the patient is not positive for dysbiosis markers, he/she will be classified as SCREENING FAILURE; if the dysbiosis is confirmed, the patient will be asked to come to another visit (V3) where he/she will undergo a MRI of the knee and a shoulder ultrasound scan in order to check for early osteoarthritis signs. Optional orthopaedic examination may be performed. Blood test will also be performed part of the samples of which will be used to evaluate biomarkers and will initially be stored at the Biobank - Cancer Center (Istituto Clinico Humanitas - Via Manzoni 56, 20089 Rozzano (MI)) with Dr. Daniela Pistillo in charge and will subsequently be processed. The other part of the blood samples on which insulin, glycated haemoglobin and glucose will be analysed will be sent to the Central Analysis Laboratory within ICH (see section 8 for details).
Objective #2 is to enrol 50 patients undergoing total knee arthroplasty (TKA). Patients scheduled to undergo TKA will undergo a pre-hospitalization orthopaedic examination (V1) where he/she will be informed about the clinical study. If he/she agrees to join the study, he/she will sign the informed consent form and will follow study procedures: questionnaires will be administered and the patient will receive a stool sample collection kit together with its instructions for use. The stool sample will be used for DNA extraction at the immunology and microbiota unit laboratory and subsequent metagenomic analysis. Patient will be instructed to hand over the stool sample during hospital visit for TKA (V2), during which intra-articular tissue samples will be collected for metagenomics. In addition, buccal swab and blood samples of the patient undergoing the surgery will be collected before surgery. Saliva, stool and blood samples for biomarkers will initially be stored at the Biobank - Cancer Center (Istituto Clinico Humanitas - Via Manzoni 56, 20089 Rozzano (MI)) under the responsibility of Dr. Daniela Pistillo and will subsequently be processed at the laboratory of the immunology and microbiota unit. The other part of the blood samples on which insulin, glycated haemoglobin and glucose will be analysed will be sent to the ICH's in-house Central Analysis Laboratory. On discharge, patient will be provided another stool collection kit. One month after surgery (V3), a follow-up examination will be performed, where patient will bring the second stool sample and will undergo another buccal swab which will also be analysed by the same laboratory (see section 8). For stool and saliva samples of V3, the storage and analysis procedure is the same as for V2. In addition, the patient will fill in the KSS questionnaires.
Objective #3 involves the enrolment of 80 patients undergoing joint revision surgery who are further divided into:
Group 1: 40 patients for septic failure of a knee or hip replacement. Group 2: 40 patients for aseptic loosening for PJI Patients will undergo a pre-hospitalization visit (V1) with orthopaedic check-up, where they will be asked to join the clinical study. Each patient will be explained the study through the means of the informed consent process, and those who wish to join the study will sign the informed consent form. Patient will be provided a stool sample collection kit for DNA extraction at the immunology and microbiota unit laboratory and subsequent metagenomic analysis. The patient will be instructed to hand over the stool sample during hospital visit for revision surgery (V2) (see section 8).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prosthesis surgery Revision of infected prosthesis
| Arm | Type | Receives |
|---|---|---|
| SURGERY | Other | Procedure: total knee replacementTOTAL KNEE REPLACEMENT SURGERY AND REVISION SURGERY OF INFECTED KNEE PROSTHESIS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- proven gut dysbiosis (increased Firmicutes/Bacteroidetes (F/B) phyla ratio and increased permeability); age range 18-50 years old.
- patients undergoing total knee replacement surgery
- patients undergoing joint revision surgery for septic failure of a knee or hip prostheses; patients undergoing revision surgery for aseptic mobilization for PJI
Key exclusion criteria (3 listed)
- musculoskeletal symptoms; previous shoulder or knee surgery; previous shoulder or knee known pathological conditions; rheumatological diseases
- any concurrent or previous diseases or conditions which might negatively affect the surgery
- major predisposing factor for gut dysbiosis (antibiotic therapy in the last 6 months, BMI > 40 and inflammatory bowel disease); chronic inflammatory joint diseases (e.g., rheumatoid arthritis, psoriatic arthritis); acute (< 90 days after the index procedure) and late hematogenous (symptoms of less than three weeks duration) infections; an inadequate amount of synovial fluid (< 10 mL) for culture, WBC, and PMN (neutrophil) percentage determinations
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 |
|---|---|---|
| total knee replacementThe Orthopedic Surgeon will remove the damaged cartilage and bone then implant the new metal and plastic knee to restore the alignment and function of your knee. The surgical procedure takes about 1-2 hours on average. While in case of infection, an antibiotic cement is inserted, which will be removed with the subsequent prosthetic implant surgery. Finally, prosthetic components can be more filling, depending on the amount of bone that is previously removed. | Procedure or surgery | SURGERY |
Primary outcome
Outcome 1 : to identify gut dysbiosis as a potential diagnostic tool for early OA.
Time frame: 1 year
The study aims to establish gut dysbiosis as a potential diagnostic tool for early OA. If a strong association between gut dysbiosis and early OA is found, it could contribute to the development of a diagnostic protocol for early OA. The identification of gut dysbiosis as an early marker of OA could represent an additional diagnostic tool, allowing for early intervention and prevention of further progression of the disease. Early recognition of OA would allow a precocious and timely intervention which could positibely alter the natural history of this condition.
Outcome 2: to investigate the intraarticular microbiota, serum LPS levels during surgery, and fecal microbiota before surgery and during recovery.
Time frame: 1 year
The analysis may reveal specific microbial imbalances or dysregulated pathways in the gut microbiota and serum LPS levels that are correlated with post-operative recovery outcomes. The study seeks to determine whether there is a correlation between the gut microbiota composition and post-operative recovery after total kneereplacement (TKA). It is expected that certain microbial taxa or functional pathways i n the gut microbiota will be associated with faster recovery, as indicated by shorter time taken to abandon crutches and higher subjective scores (e.g., KneeSociety Score, KSS score). The study aims to investigate the role of the gut microbiota as a predicting factor for joint arthroplasty recovery. If a significant correlation is found between specific microbial imbalances or dysregulated pathways and post-operative recovery outcomes, it could indicate that the gut microbiota can serve as a predictive factor for recoveryafter TKA.
Outcome 3: to investigate if periprosthetic joint infections (PJI) influences gut microbiota environment predisposing to gut dysbiosis, which negatively affects life expectancy in these patients.
Time frame: 1 year
The analysis may reveal specific microbial imbalances or dysregulated pathways in the gut microbiota that are correlated with the presence of PJI. It is expected that patients with PJI will exhibit distinct alterations in the gut microbiota compared to patients undergoing revision surgery for aseptic mobilization. The analysis may establish a correlation between specific microbial taxa or functional pathways in the gut microbiota and the occurrence of PJI.
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 25 Apr 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.
TOMMASO BONANZINGA principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Questions about this trial
What is this clinical trial studying?
A study testing total knee replacement in people with Knee Prosthesis and Knee Prosthesis Infection, run by Istituto Clinico Humanitas.
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 3 inclusion and 3 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 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
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 ROBERTA TALLARITA (0282247770, roberta.tallarita@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome 1 : to identify gut dysbiosis as a potential diagnostic tool for early OA. (time frame: 1 year). The study lists 3 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 25 Apr 2025.