Clostridium Difficile InfectionPhase 3COLONIZENCT03796650
Fecal Transplantation for Primary Clostridium Difficile Infection
A Phase 3 study testing Fecal microbiota transplantation and Vancomycin in people with Clostridium Difficile Infection, run by Oslo University Hospital at 18 sites in Norway.
Trial summary
In this randomized controlled trial the investigators want to compare the effect of one-time rectal instillation of fecal microbiota transplantation, compared to a ten-day antibiotic course for the treatment of primary Clostridium difficile infection (CDI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Fecal microbiota transplantation and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 18 sitesNorway
- Study dates
- 17 Jul 2019to 2 Apr 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, ≥18 years with primary C. difficile infection, defined by the following three criteria:
- Diarrhea as defined by the WHO (≥3 loose stools per day), and
- Positive stool test for toxin producing C. difficile, and
- No evidence of previous C. difficile infection during 365 days before enrolment.
- Written informed consent
Who cannot join
- Known presence of other stool pathogens known to cause diarrhea.
- Ongoing antibiotic treatment for other infections that cannot be stopped before study treatment administration.
- Inflammatory bowel disease or microscopic colitis.
- \< 3 months life expectancy.
- Serious immunodeficiency, defined as one of the following:
- Ongoing or recent chemotherapy and current or expected neutropenia with neutrophil count of \< 500/μL.
Show all 15Show fewer
- Active severe immunocompromising disease.
- Inability to comply with protocol requirements.
- Need of intensive care.
- Known irritable bowel syndrome, diarrheal type.
- Pregnancy or nursing.
- Known or suspected toxic megacolon or ileus.
- Total or subtotal colectomy, ileostomy or colonostomy.
- Contraindications for rectal catheter insertion
- Known hypersensitivity or other contraindications to vancomycin
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Norway18 sites
Ålesund Sjukehus
Ålesund
Haukeland universitetssykehus
Bergen
Nordlandssykehuset
Bodø, 8092
Sykehuset Østfold Kalnes
Grålum
UNN Harstad
Harstad
Sørlandet Hospital HF
Kristiansand
Sykehuset Levanger
Levanger
Sykehuset Innlandet HF
Lillehammer
Akershus University Hospital
Lørenskog, 1478
Diakonhjemmet Hospital
Oslo, Oslo, 0319
Lovisenberg sykehus
Oslo
Oslo University Hospital Rikshospitalet
Oslo
Oslo University Hospital Ullevål
Oslo
Vestre Viken HF, Bærum Hospital
Sandvika, Gjettum, 1346
Telemark Hospital HF
Skien
Stavanger University Hospital
Stavanger
Sykehuset i Vestfold
Tønsberg
UNN Tromsø
Tromsø
About this study
Official title: COmparative Effectiveness of IntestinaL MicrobiOta Versus VaNcomycin for Primary C. Difficile Infection - RandomiZEd Trials
In this randomized controlled trial the investigators want to compare the effect of one-time rectal instillation of fecal microbiota transplantation, compared to a ten-day antibiotic course for the treatment of primary Clostridium difficile infection (CDI). The investigators hypothetsize that the instillation of feces from a healthy donor will be non-inferior to vancomycin in inducing a durable cure.
Read the detailed description
Up to one third of patients with clostridium difficile infection treated with antibiotics experience recurrent or relapsing symptoms within a few weeks. Even with subsequent antibiotic treatment, multiple recurrences/relapses are frequent. Fecal microbiota transplantation (FMT) has been shown to be significantly more effective in curing recurrent CDI than repeated antibiotic treatment. In current guidelines, FMT is proposed as a treatment option after multiple recurrences/relapses of CDI. The rationale to reserve transplantation of donor feces for recurrent and difficult cases of CDI is a possible risk of pathogen transmittance and the process of finding a donor and screen for communicable disease.
The effect of FMT for recurrent CDI, however, suggests that this therapy may be more effective than antibiotics in inducing a durable cure also for primary CDI. If the therapeutic effect of FMT proves to be equal (non-inferior) or more effective than antibiotics, FMT may be the preferable treatment option due to favourable ecological impact compared to antibiotics. In an era with increasing concerns about overuse of antibiotics and emergence of antibiotic resistant bacteria, it is important to investigate therapeutic alternatives that may reduce the need for antibiotics.
This trial is a phase III multicentre, randomized controlled, open-label non-inferiority parallel group trial with two arms (FMT and antibiotics), and is a continuation of the phase II trial IMT for Primary Clostridium Difficile Infection (NCT02301000). In the current trial, patients with Clostridium difficile infection and no previous CDI within 12 months prior to inclusion will be randomized 1:1 to FMT or 10 days of guideline-recommended antibiotic therapy (vancomycin 125 mg four times a day).
Patients are recruited in Norwegian hospitals.
The investigators plan to use frozen microbiota, because supply is easier to organize, compared to fresh fecal samples. Patients in the FMT treatment group will receive one rectal dose of FMT, originating from screened, healthy donors. Patients who are not cured by the first dose is offered a protocol defined additional FMT treatment. In the case of clinical deterioration, appropriate measures will be undertaken according to current guidelines.
Patient treatment outcomes are evaluated after 14, 60 and 365 days from inclusion and treatment initiation.
An interim analysis is planned after inclusion of the first 94 patients (corresponding to 50% of the planned number of patients).
- Conditions
- Clostridium Difficile Infection
- Being tested
- Fecal microbiota transplantation, Vancomycin
- Keywords
- Clostridium difficile, Intestinal microbiota therapy, Fecal microbiota transplantation, Investigator-initiated, Antibiotics, Diarrhea
- Medical subject headings
- Clostridium Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationOther
Also called FMT, IMT, Bacteriotherapy
50 g donor feces suspended in saline with added glycerol, administered by a enema kit.
VancomycinDrug
Peroral vancomycin 125 mg q.i.d. for ten days.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Fecal microbiota from healthy, screened stool donors at the University Hospital of North Norway. Patients will receive one FMT enema immediately after enrolment. Receives: Other: Fecal microbiota transplantation |
| Antibiotic treatment | Active comparator | Patients randomized to the control group will receive a ten-day course of oral vancomycin four times a day. This is according to international guidelines for primary C. difficile treatment. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with durable cure
Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, with the assigned treatment alone.
Measured: 60 days
Secondary outcomes (4)
Patients with durable cure with additional treatment.
Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, with or without the need of additional treatment (FMT, metronidazole or vancomycin).
Measured: 60 days
Treatment adverse events
Proportion of patients with adverse events.
Measured: 60 and 365 days
Patients with long-time cure
Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, and without recurrent C. difficile infection within 365 days after treatment start.
Measured: 365 days
Health-economic evaluation
Health-economic analysis of the two compared treatment modalities
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start17 Jul 2019
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Why it stopped: Pre-specified non-inferiority criterion met at interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with two parallel treatment arms with a 1:1 allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, University Hospital of North Norway, Haukeland University Hospital, Helse Nord-Trøndelag HF, Vestre Viken Hospital Trust, The Hospital of Vestfold, Sykehuset Telemark, Alesund Hospital, University Hospital, Akershus, Lovisenberg Diakonale Hospital, Sorlandet Hospital HF, Ostfold Hospital Trust, Diakonhjemmet Hospital, Nordlandssykehuset HF, Sykehuset Innlandet HF, Helse Stavanger HF
- Responsible party
- Principal investigator, Kjetil Garborg, Oslo University Hospital
- Investigators
- Michael Bretthauer, MD, PhD, Study chair, Oslo Universitetssykehus HF, Rikshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796650
- Sponsor's protocol ID
- COLONIZE
- Acronym
- COLONIZE
- Status last verified
- Sep 2024
- First submitted
- 4 Jan 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The trial adheres to data sharing policies of the ICMJE. Data sharing is considered for each request by the principal investigators. Data sharing is not granted if they overlap with planned analyses. Data sharing requires all approvals by relevant authorities. Costs for data sharing will not be covered by the study group.
Publications
McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, Dubberke ER, Garey KW, Gould CV, Kelly C, Loo V, Shaklee Sammons J, Sandora TJ, Wilcox MH. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):987-994. doi: 10.1093/cid/ciy149.
PubMed 29562266Juul FE, Garborg K, Bretthauer M, Skudal H, Oines MN, Wiig H, Rose O, Seip B, Lamont JT, Midtvedt T, Valeur J, Kalager M, Holme O, Helsingen L, Loberg M, Adami HO. Fecal Microbiota Transplantation for Primary Clostridium difficile Infection. N Engl J Med. 2018 Jun 28;378(26):2535-2536. doi: 10.1056/NEJMc1803103. Epub 2018 Jun 2. No abstract available.
PubMed 29860912Leffler DA, Lamont JT. Clostridium difficile infection. N Engl J Med. 2015 Apr 16;372(16):1539-48. doi: 10.1056/NEJMra1403772. No abstract available.
PubMed 25875259van Nood E, Dijkgraaf MG, Keller JJ. Duodenal infusion of feces for recurrent Clostridium difficile. N Engl J Med. 2013 May 30;368(22):2145. doi: 10.1056/NEJMc1303919. No abstract available.
PubMed 23718168Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19.
PubMed 23511459Juul FE, Bretthauer M, Johnsen PH, Samy F, Tonby K, Berdal JE, Hoff DAL, Ofstad EH, Abraham A, Seip B, Wiig H, Rognstad OB, Glad IF, Valeur J, Nissen-Lie AE, Ness-Jensen E, Lund KMA, Skjevling LK, Hanevik K, Skudal H, Melsom EJ, Boyar R, Cooper TJ, Ranheim TE, Riise EM, Adami HO, Kalager M, Loberg M, Garborg KK. Fecal Microbiota Transplantation Versus Vancomycin for Primary Clostridioides difficile Infection : A Randomized Controlled Trial. Ann Intern Med. 2025 Jul;178(7):940-947. doi: 10.7326/ANNALS-24-03285. Epub 2025 Jun 17.
PubMed 40523286
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparative Effectiveness of IntestinaL MicrobiOta Versus VaNcomycin for Primary C. Difficile Infection - RandomiZEd Trials
- ClinicalTrials.gov ID
- NCT03796650
- Acronym / sponsor ID
- COLONIZE / COLONIZE
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile, Intestinal microbiota therapy, Fecal microbiota transplantation, Investigator-initiated, Antibiotics, Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pre-specified non-inferiority criterion met at interim analysis.
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, University Hospital of North Norway, Haukeland University Hospital, Helse Nord-Trøndelag HF, Vestre Viken Hospital Trust, The Hospital of Vestfold, Sykehuset Telemark, Alesund Hospital, University Hospital, Akershus, Lovisenberg Diakonale Hospital, Sorlandet Hospital HF, Ostfold Hospital Trust, Diakonhjemmet Hospital, Nordlandssykehuset HF, Sykehuset Innlandet HF, Helse Stavanger HF
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 8 Jan 2019 (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.
In this randomized controlled trial the investigators want to compare the effect of one-time rectal instillation of fecal microbiota transplantation, compared to a ten-day antibiotic course for the treatment of primary Clostridium difficile infection (CDI). The investigators hypothetsize that the instillation of feces from a healthy donor will be non-inferior to vancomycin in inducing a durable cure.
Detailed description
Up to one third of patients with clostridium difficile infection treated with antibiotics experience recurrent or relapsing symptoms within a few weeks. Even with subsequent antibiotic treatment, multiple recurrences/relapses are frequent. Fecal microbiota transplantation (FMT) has been shown to be significantly more effective in curing recurrent CDI than repeated antibiotic treatment. In current guidelines, FMT is proposed as a treatment option after multiple recurrences/relapses of CDI. The rationale to reserve transplantation of donor feces for recurrent and difficult cases of CDI is a possible risk of pathogen transmittance and the process of finding a donor and screen for communicable disease.
The effect of FMT for recurrent CDI, however, suggests that this therapy may be more effective than antibiotics in inducing a durable cure also for primary CDI. If the therapeutic effect of FMT proves to be equal (non-inferior) or more effective than antibiotics, FMT may be the preferable treatment option due to favourable ecological impact compared to antibiotics. In an era with increasing concerns about overuse of antibiotics and emergence of antibiotic resistant bacteria, it is important to investigate therapeutic alternatives that may reduce the need for antibiotics.
This trial is a phase III multicentre, randomized controlled, open-label non-inferiority parallel group trial with two arms (FMT and antibiotics), and is a continuation of the phase II trial IMT for Primary Clostridium Difficile Infection (NCT02301000). In the current trial, patients with Clostridium difficile infection and no previous CDI within 12 months prior to inclusion will be randomized 1:1 to FMT or 10 days of guideline-recommended antibiotic therapy (vancomycin 125 mg four times a day).
Patients are recruited in Norwegian hospitals.
The investigators plan to use frozen microbiota, because supply is easier to organize, compared to fresh fecal samples. Patients in the FMT treatment group will receive one rectal dose of FMT, originating from screened, healthy donors. Patients who are not cured by the first dose is offered a protocol defined additional FMT treatment. In the case of clinical deterioration, appropriate measures will be undertaken according to current guidelines.
Patient treatment outcomes are evaluated after 14, 60 and 365 days from inclusion and treatment initiation.
An interim analysis is planned after inclusion of the first 94 patients (corresponding to 50% of the planned number of patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with two parallel treatment arms with a 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Other: Fecal microbiota transplantationFecal microbiota from healthy, screened stool donors at the University Hospital of North Norway. Patients will receive one FMT enema immediately after enrolment. |
| Antibiotic treatment | Active comparator | Drug: VancomycinPatients randomized to the control group will receive a ten-day course of oral vancomycin four times a day. This is according to international guidelines for primary C. difficile treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients, ≥18 years with primary C. difficile infection, defined by the following three criteria:
- Written informed consent
Key exclusion criteria (15 listed)
- Known presence of other stool pathogens known to cause diarrhea.
- Ongoing antibiotic treatment for other infections that cannot be stopped before study treatment administration.
- Inflammatory bowel disease or microscopic colitis.
- \< 3 months life expectancy.
- Serious immunodeficiency, defined as one of the following:
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 transplantationAlso: FMT, IMT, Bacteriotherapy50 g donor feces suspended in saline with added glycerol, administered by a enema kit. | Other | Fecal microbiota transplantation |
| VancomycinPeroral vancomycin 125 mg q.i.d. for ten days. | Drug | Antibiotic treatment |
Primary outcome
Patients with durable cure
Time frame: 60 days
Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, with the assigned treatment alone.
4 secondary outcomes
Patients with durable cure with additional treatment.
Time frame: 60 days
Treatment adverse events
Time frame: 60 and 365 days
Patients with long-time cure
Time frame: 365 days
Health-economic evaluation
Time frame: 365 days
Results and safety
The study was stopped early (reason given: Pre-specified non-inferiority criterion met at interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 29562266McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, Dubberke ER, Garey KW, Gould CV, Kelly C, Loo V, Shaklee Sammons J, Sandora TJ, Wilcox MH. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):987-994. doi: 10.1093/cid/ciy149.
- Background: PubMed 29860912Juul FE, Garborg K, Bretthauer M, Skudal H, Oines MN, Wiig H, Rose O, Seip B, Lamont JT, Midtvedt T, Valeur J, Kalager M, Holme O, Helsingen L, Loberg M, Adami HO. Fecal Microbiota Transplantation for Primary Clostridium difficile Infection. N Engl J Med. 2018 Jun 28;378(26):2535-2536. doi: 10.1056/NEJMc1803103. Epub 2018 Jun 2. No abstract available.
- Background: PubMed 25875259Leffler DA, Lamont JT. Clostridium difficile infection. N Engl J Med. 2015 Apr 16;372(16):1539-48. doi: 10.1056/NEJMra1403772. No abstract available.
- Background: PubMed 23718168van Nood E, Dijkgraaf MG, Keller JJ. Duodenal infusion of feces for recurrent Clostridium difficile. N Engl J Med. 2013 May 30;368(22):2145. doi: 10.1056/NEJMc1303919. No abstract available.
- Background: PubMed 23511459Kassam Z, Lee CH, Yuan Y, Hunt RH. Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis. Am J Gastroenterol. 2013 Apr;108(4):500-8. doi: 10.1038/ajg.2013.59. Epub 2013 Mar 19.
- Derived from this study: PubMed 40523286Juul FE, Bretthauer M, Johnsen PH, Samy F, Tonby K, Berdal JE, Hoff DAL, Ofstad EH, Abraham A, Seip B, Wiig H, Rognstad OB, Glad IF, Valeur J, Nissen-Lie AE, Ness-Jensen E, Lund KMA, Skjevling LK, Hanevik K, Skudal H, Melsom EJ, Boyar R, Cooper TJ, Ranheim TE, Riise EM, Adami HO, Kalager M, Loberg M, Garborg KK. Fecal Microbiota Transplantation Versus Vancomycin for Primary Clostridioides difficile Infection : A Randomized Controlled Trial. Ann Intern Med. 2025 Jul;178(7):940-947. doi: 10.7326/ANNALS-24-03285. Epub 2025 Jun 17.
- Investigating research group' home pageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The trial adheres to data sharing policies of the ICMJE. Data sharing is considered for each request by the principal investigators. Data sharing is not granted if they overlap with planned analyses. Data sharing requires all approvals by relevant authorities. Costs for data sharing will not be covered by the study group.
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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.
Michael Bretthauer, MD, PhD study chair
Oslo Universitetssykehus HF, Rikshospitalet
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fecal microbiota transplantation and Vancomycin in people with Clostridium Difficile Infection, run by Oslo University Hospital at 18 sites in Norway.
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 15 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: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Norway. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Pre-specified non-inferiority criterion met at interim analysis.). Results are not available in the source record.
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?
Patients with durable cure (time frame: 60 days). 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 NCT03796650, which also lists 6 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 19 Sep 2024.