Fecal Microbiota TransplantationPhase 2NCT06205862
Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)
A Phase 2 study testing fecal microbiota transplantation in people with Fecal Microbiota Transplantation and Colorectal Adenoma, run by Shenzhen Hospital of Southern Medical University at 5 sites in China.
Trial summary
The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fecal Microbiota Transplantation, Colorectal Adenoma, Gastrointestinal Microbiome
- What is being tested?
- fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 5 sitesChina
- Study dates
- 9 Apr 2024to Dec 2028
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75, gender not specified.
- Colorectal adenoma patients diagnosed by colonoscopy and treated with endoscopic resection (such as EMR, ESD, APC treatment, etc.)，or patients who have undergone endoscopic resection within the past 6 months and have pathologically confirmed colorectal adenoma.
- Individuals who are able to swallow pills/capsules.
- Individuals who voluntarily sign an informed consent form after fully understanding the purpose and procedures of this study, the characteristics of the disease, the therapeutic efficacy of the drugs, the related examination methods, and the potential risks/benefits of the study.
Who cannot join
- Individuals in whom the adenoma was not completely removed in a previous colonoscopy;
- Individuals who experienced serious complications during or after adenoma resection, including perforation, uncontrollable bleeding, or severe infection;
- Individuals with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC/Lynch syndrome);
- Individuals regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase 2 (COX2) inhibitors, calcium, or vitamin D;
- Individuals with a history of subtotal or total gastrectomy or partial bowel resection;
- People who cannot tolerate colonoscopy;
Show all 13Show fewer
- Individuals with allergic diathesis, known allergies to fecal microbiota transplantation, drug allergies, or intolerance;
- Individuals with serious heart, liver, or kidney diseases, or any history of cancer;
- People suffering from severe constipation;
- Pregnant women, breastfeeding mothers, or women planning to become pregnant;
- Patients with mental illness who are unable to cooperate;
- Individuals involved in the design, planning, or execution of this trial;
- Any other individuals who, in the investigator's opinion, are unsuitable for inclusion.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 4 recruiting
- Withdrawn
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
- Recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518000
Jun Huang, +8613189606428, 1473355495@qq.com
Ye Chen, MD, chenye_2013@163.com
- Not yet recruiting
Luohu District People's Hospital
Shenzhen, Guangdong
Jun huang
- Not yet recruiting
Shenzhen University General Hospital
Shenzhen, Guangdong
Jun Huang
- Not yet recruiting
Shunde Hospital of Southern Medical University
Shunde, Guangdong
Jun Huang
About this study
Official title: Efficacy and Safety of Fecal Microbiota Transplantation in Reducing Recurrence of Colorectal Adenomas After Endoscopic Resection: a Multicenter, Open-label, Randomized Controlled Study
The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection.
The main questions it aims to answer are:
Read more
- the efficacy and safety of fecal microbiota transplantation in reducing the recurrence rate of colorectal adenomas after endoscopic resection.
- changes in the intestinal and mucosal microbiota of patients before and after endoscopic treatment.
- changes in the intestinal and mucosal microbiota of patients before and after fecal microbiota transplantation.
Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).
Read the detailed description
Colorectal adenomas are precancerous lesions that can lead to colorectal cancer if not effectively managed. The standard treatment for colorectal adenomas is endoscopic resection. However, there is a significant rate of recurrence following this procedure, which poses a challenge for long-term management and prevention of colorectal cancer. Recent research has suggested a potential role for the gut microbiota in the development and recurrence of colorectal adenomas. Fecal microbiota transplantation (FMT) has been proposed as a novel strategy to manipulate the microbiota to reduce the recurrence of these lesions. This clinical trial aims to investigate both the efficacy and safety of FMT in reducing the recurrence of colorectal adenomas post endoscopic resection, and to elucidate the changes in intestinal and mucosal microbiota associated with the treatment.
The clinical trial is designed as a randomized controlled study where participants who have undergone endoscopic resection for colorectal adenomas are enrolled to receive FMT. The primary objective is to assess the efficacy of FMT in reducing the recurrence rate of colorectal adenomas. The secondary objective is to evaluate the safety of FMT in this patient population and to examine the changes in intestinal and mucosal microbiota before and after endoscopic treatment and FMT.
Participants are required to undergo a baseline colonoscopy to ensure the absence of residual adenomas post endoscopic resection. Following this, on day 0, participants will receive their first FMT via infusion of 150ml of fecal suspension into the terminal ileum under endoscopic guidance. This procedure aims to directly alter the gut microbiota by introducing a healthy donor's fecal material.
The FMT treatment is continued orally in the form of capsules for the next two days. Participants are instructed to ingest a considerable number of FMT capsules (40 capsules per day, 20 capsules twice daily) to maintain the introduced microbiota's presence and potential therapeutic effect.
After the initial intensive treatment phase, participants enter a maintenance phase where they receive oral FMT capsules at 3, 6, and 9 months (approximately every 75 to 90 days). This phase is designed to establish a newly balanced and potentially disease-modifying gut microbiome, allowing for a longitudinal assessment of the FMT's efficacy in reducing adenoma recurrence.
Safety assessments are performed throughout the trial, including monitoring for adverse events related to the FMT procedure and the overall health status of participants. Stool samples are collected at various time points to analyze changes in the gut microbiota composition using molecular techniques.
This clinical trial represents a critical step in understanding the potential role of FMT in preventing the recurrence of colorectal adenomas following endoscopic resection. By investigating both the efficacy and safety of FMT, as well as the associated changes in the gut microbiota, this study could significantly contribute to the development of novel therapeutic strategies for colorectal cancer prevention. If successful, this approach could provide a non-invasive and potentially effective treatment modality for patients at risk of recurrent colorectal adenomas, ultimately improving patient outcomes and reducing the burden of colorectal cancer.
- Being tested
- fecal microbiota transplantation
- Keywords
- Fecal Microbiota Transplantation, Colorectal Adenomas, Gastrointestinal Microbiome, Recurrence rate after endoscopic resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiota transplantationProcedure or surgery
We will use fecal suspensions and capsules prepared from the feces of healthy donors for fecal microbiota transplantation. Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).
| Study group | Role | What they receive |
|---|---|---|
| FMT group | Experimental | Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months). Receives: Procedure: fecal microbiota transplantation |
| No treatment group | No intervention | Participants are required to complete one colonoscopy and during the procedure, 150ml of saline is infused into the terminal ileum on day 0. Subsequently, participants don't need any treatment. The participants will receive their first colonoscopy follow-up 6 to 12 months after enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRA recurrence rate
Percentage of patients who has recurrence of CRA(colorectal adenoma) during or after FMT.
Measured: 6~12 months
Secondary outcomes (5)
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0
The number of participants with adverse events both severe and non-severe, assessed for severity based on the 5-grade criteria set by the NCI CTCAE version 5.0.
Measured: 1~12 months
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Outcomes assessed included alpha and beta diversity, etc.
Measured: 1~12 months
All polypoid lesions incidence rate
Percentage of patients who has incidence of all polypoid lesions during or after FMT.
Measured: 6~12 months
CRC incidence rate
Percentage of patients who has incidence of CRC (colorectal cancer) during or after FMT.
Measured: 6~12 months
Changes in intestinal mucosal microbiota Pre- and Post-FMT
Intestinal mucosal microbiota tests (16S rRNA gene sequencing, metagenome sequencing).
Measured: 1~12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start9 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal Microbiota TransplantationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 466 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hospital of Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Ye, Shenzhen Hospital of Southern Medical University
- Investigators
- Ye Chen, MD, Principal investigator, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205862
- Sponsor's protocol ID
- 20231219v2.6
- Status last verified
- Jul 2024
- First submitted
- 19 Dec 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang J, Chen Z, Wang M, Yang C, Wang A, Chen Y. Efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection: study protocol for a multicenter, open-label, randomized, no-treatment-controlled trial. Trials. 2026 Apr 27;27(1):435. doi: 10.1186/s13063-026-09740-1.
PubMed 42045958
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fecal Microbiota Transplantation in Reducing Recurrence of Colorectal Adenomas After Endoscopic Resection: a Multicenter, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06205862
- Acronym / sponsor ID
- 20231219v2.6
- Keywords
- Fecal Microbiota Transplantation, Colorectal Adenomas, Gastrointestinal Microbiome, Recurrence rate after endoscopic resection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 466 participants (estimated)
- Lead sponsor
- Shenzhen Hospital of Southern Medical UniversityUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 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.
The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection.
The main questions it aims to answer are:
- the efficacy and safety of fecal microbiota transplantation in reducing the recurrence rate of colorectal adenomas after endoscopic resection.
- changes in the intestinal and mucosal microbiota of patients before and after endoscopic treatment.
- changes in the intestinal and mucosal microbiota of patients before and after fecal microbiota transplantation.
Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).
Detailed description
Colorectal adenomas are precancerous lesions that can lead to colorectal cancer if not effectively managed. The standard treatment for colorectal adenomas is endoscopic resection. However, there is a significant rate of recurrence following this procedure, which poses a challenge for long-term management and prevention of colorectal cancer. Recent research has suggested a potential role for the gut microbiota in the development and recurrence of colorectal adenomas. Fecal microbiota transplantation (FMT) has been proposed as a novel strategy to manipulate the microbiota to reduce the recurrence of these lesions. This clinical trial aims to investigate both the efficacy and safety of FMT in reducing the recurrence of colorectal adenomas post endoscopic resection, and to elucidate the changes in intestinal and mucosal microbiota associated with the treatment.
The clinical trial is designed as a randomized controlled study where participants who have undergone endoscopic resection for colorectal adenomas are enrolled to receive FMT. The primary objective is to assess the efficacy of FMT in reducing the recurrence rate of colorectal adenomas. The secondary objective is to evaluate the safety of FMT in this patient population and to examine the changes in intestinal and mucosal microbiota before and after endoscopic treatment and FMT.
Participants are required to undergo a baseline colonoscopy to ensure the absence of residual adenomas post endoscopic resection. Following this, on day 0, participants will receive their first FMT via infusion of 150ml of fecal suspension into the terminal ileum under endoscopic guidance. This procedure aims to directly alter the gut microbiota by introducing a healthy donor's fecal material.
The FMT treatment is continued orally in the form of capsules for the next two days. Participants are instructed to ingest a considerable number of FMT capsules (40 capsules per day, 20 capsules twice daily) to maintain the introduced microbiota's presence and potential therapeutic effect.
After the initial intensive treatment phase, participants enter a maintenance phase where they receive oral FMT capsules at 3, 6, and 9 months (approximately every 75 to 90 days). This phase is designed to establish a newly balanced and potentially disease-modifying gut microbiome, allowing for a longitudinal assessment of the FMT's efficacy in reducing adenoma recurrence.
Safety assessments are performed throughout the trial, including monitoring for adverse events related to the FMT procedure and the overall health status of participants. Stool samples are collected at various time points to analyze changes in the gut microbiota composition using molecular techniques.
This clinical trial represents a critical step in understanding the potential role of FMT in preventing the recurrence of colorectal adenomas following endoscopic resection. By investigating both the efficacy and safety of FMT, as well as the associated changes in the gut microbiota, this study could significantly contribute to the development of novel therapeutic strategies for colorectal cancer prevention. If successful, this approach could provide a non-invasive and potentially effective treatment modality for patients at risk of recurrent colorectal adenomas, ultimately improving patient outcomes and reducing the burden of colorectal cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT group | Experimental | Procedure: fecal microbiota transplantationParticipants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months). |
| No treatment group | No intervention | –Participants are required to complete one colonoscopy and during the procedure, 150ml of saline is infused into the terminal ileum on day 0. Subsequently, participants don't need any treatment. The participants will receive their first colonoscopy follow-up 6 to 12 months after enrollment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75, gender not specified.
- Colorectal adenoma patients diagnosed by colonoscopy and treated with endoscopic resection (such as EMR, ESD, APC treatment, etc.)，or patients who have undergone endoscopic resection within the past 6 months and have pathologically confirmed colorectal adenoma.
- Individuals who are able to swallow pills/capsules.
- Individuals who voluntarily sign an informed consent form after fully understanding the purpose and procedures of this study, the characteristics of the disease, the therapeutic efficacy of the drugs, the related examination methods, and the potential risks/benefits of the study.
Key exclusion criteria (13 listed)
- Individuals in whom the adenoma was not completely removed in a previous colonoscopy;
- Individuals who experienced serious complications during or after adenoma resection, including perforation, uncontrollable bleeding, or severe infection;
- Individuals with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC/Lynch syndrome);
- Individuals regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase 2 (COX2) inhibitors, calcium, or vitamin D;
- Individuals with a history of subtotal or total gastrectomy or partial bowel resection;
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 |
|---|---|---|
| fecal microbiota transplantationWe will use fecal suspensions and capsules prepared from the feces of healthy donors for fecal microbiota transplantation. Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months). | Procedure or surgery | FMT group |
Primary outcome
CRA recurrence rate
Time frame: 6~12 months
Percentage of patients who has recurrence of CRA(colorectal adenoma) during or after FMT.
5 secondary outcomes
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0
Time frame: 1~12 months
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Time frame: 1~12 months
All polypoid lesions incidence rate
Time frame: 6~12 months
CRC incidence rate
Time frame: 6~12 months
Changes in intestinal mucosal microbiota Pre- and Post-FMT
Time frame: 1~12 months
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 15 Jul 2024.
- Derived from this study: PubMed 42045958Huang J, Chen Z, Wang M, Yang C, Wang A, Chen Y. Efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection: study protocol for a multicenter, open-label, randomized, no-treatment-controlled trial. Trials. 2026 Apr 27;27(1):435. doi: 10.1186/s13063-026-09740-1.
- 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.
Ye Chen, MD principal investigator
Shenzhen Hospital of Southern Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fecal microbiota transplantation in people with Fecal Microbiota Transplantation and Colorectal Adenoma, run by Shenzhen Hospital of Southern Medical University at 5 sites 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 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Huang (+8613189606428, 1473355495@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRA recurrence rate (time frame: 6~12 months). 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 NCT06205862, which also lists 1 linked publication.
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 15 Jul 2024.