Chronic RhinosinusitisPhase 2/3NCT03229551
Xylitol for Chronic Sinusitis
A Phase 2/3 study testing Xylitol and Saline in people with Chronic Rhinosinusitis and Rhinosinusitis, run by Ochsner Health System at 1 site in United States.
Trial summary
The purpose of this investigation is to conduct a randomized controlled trial within a subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt biofilms and improve disease control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis, Rhinosinusitis, Sinusitis
- What is being tested?
- Xylitol and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 16 Jul 2018
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients above the age of 18
- History of chronic rhinosinusitis history who had undergone bilateral endoscopic sinus surgery to include at a minimum maxillary antrostomy and anterior ethmoidectomy.
- Continued chronic sinusitis that is refractory to medical therapy after surgical intervention
Who cannot join
- Patients under age of 18
- Non-English speaking
- History of immunodeficiency disease
- Cystic fibrosis
- Primary ciliary dyskinesia
- History of granulomatous disease
Show all 11Show fewer
- Active smoker
- Treatment with antifungal medications
- Use of antifungal medications
- Acute bacterial infection requiring antibiotics
- Active pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Medical Center
New Orleans, Louisiana, 70121
About this study
Official title: Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis
The purpose of this investigation is to conduct a randomized controlled trial within a subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt biofilms and improve disease control. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields. Specifically, the investigators will be studying the effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.
Read the detailed description
Problem Statement:
The purpose of this investigation is to conduct a trial within a subgroup of difficult-to-treat patients with CRS. This difficult group of patients will have undergone an exhaustive surgical and medical treatment of CRS These patient often will be frustrated with the lack of improvement in their symptoms despite maximal medical and surgical therapy. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields.
Purpose of Study/Potential Impact:
The purpose of this investigation is to conduct a randomized controlled trial within a subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt biofilms and improve disease control. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields.
Potential Benefits:
Topical xylitol could potentially decrease CRS symptoms, leading to improvements in patient quality of life. This decrease could potentially lead to fewer visits to primary care physicians/otolaryngologists. These could lead to less antibiotics, radiographs being obtained and unnecessary surgical procedures being performed, all of which could potentially reduce the burden of medical expenditure in the treatment of this disease.
Potential Risks:
Potential risks are minimal but include a sweet aftertaste in the mouth and burning in the nose; which have been reported in previous studies.
Hypothesis:
5% (wt/vol) Xylitol saline irrigation into the diseased paranasal sinus, as a part of a post-ESS refractory CRS management plan, will reduce biofilm formation in the sinus and result in symptomatic relief in affected patients.
General Design:
A prospective, randomized, double-blinded experimental design will be utilized. Patients will be randomized into the xylitol-saline treatment arm versus the control saline arm. Concurrent corticosteroid/antibiotic therapy will be utilized in both arms based on results of bacterial DNA sequencing. Patients will undergo weekly in-office irrigations for three weeks and will be evaluated one month and three months post-treatment. The postoperative care will be standardized across all participants.
- Conditions
- Chronic Rhinosinusitis, Rhinosinusitis, Sinusitis, Drain Sinus, Endoscopic Sinus Surgery, Biofilms
- Being tested
- Xylitol, Saline
- Keywords
- chronic rhinosinusitis, chronically draining sinus, condemned sinus, post-endoscopic sinus surgery
- Medical subject headings
- Rhinosinusitis, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylitolDrug
Topical 5% Xylitol (wt/vol) diluted in saline nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.
SalineDrug
Saline as a standard-of-care nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.
| Study group | Role | What they receive |
|---|---|---|
| Xylitol | Experimental | This arm will evaluate the effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention. Receives: Drug: Xylitol |
| Control | Active comparator | This arm is the standard of care saline irrigation solution. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.
Bacterial DNA sequencing obtained via endoscopic swab will be performed pre-treatment to analyse the presence of biofims in the diseased sinus. This assay will be repeated from the same sinus post-treatment with 5% Xylitol (wt/vol) to evaluate if medical intervention decreases biofilm production in the diseased sinus.
Measured: 3 months
Secondary outcomes (4)
Sino-Nasal Outcome Test-22 (SNOT-22)
Maximum score of 110 points based on responses to 22 questions
Measured: 3 months
Brief Smell Identification Test (BSIT)
Total scores range from 0 to 12; higher scores indicate greater olfactory function
Measured: 3 months
Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol
Measured: 3 months
Correlation of DNA seqeuncing results with conventional sinonasal cultures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Mar 2018
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University School of Medicine
- Responsible party
- Principal investigator, Edward Mccoul, MD, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229551
- Sponsor's protocol ID
- 2017.317.B
- Status last verified
- Apr 2023
- First submitted
- 21 Jul 2017
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be presented in either a paper or electronic format. Upon its arrival, it will immediately be de-identified. If presented in a paper format, it will immediately be transferred into an electronic database. Only key personnel will have access to this data. The data will be encrypted and stored on permanent hardware or within the Ochsner secure network on a password-protected workstation.
Publications
Harvey RJ, Psaltis A, Schlosser RJ, Witterick IJ. Current concepts in topical therapy for chronic sinonasal disease. J Otolaryngol Head Neck Surg. 2010 Jun;39(3):217-31.
PubMed 20470665Al-Mutairi D, Kilty SJ. Bacterial biofilms and the pathophysiology of chronic rhinosinusitis. Curr Opin Allergy Clin Immunol. 2011 Feb;11(1):18-23. doi: 10.1097/ACI.0b013e3283423376.
PubMed 21150431Hoggard M, Wagner Mackenzie B, Jain R, Taylor MW, Biswas K, Douglas RG. Chronic Rhinosinusitis and the Evolving Understanding of Microbial Ecology in Chronic Inflammatory Mucosal Disease. Clin Microbiol Rev. 2017 Jan;30(1):321-348. doi: 10.1128/CMR.00060-16.
PubMed 27903594Rosen PL, Palmer JN, O'Malley BW Jr, Cohen NA. Surfactants in the management of rhinopathologies. Am J Rhinol Allergy. 2013 May-Jun;27(3):177-80. doi: 10.2500/ajra.2013.27.3873.
PubMed 23710951Riley P, Moore D, Ahmed F, Sharif MO, Worthington HV. Xylitol-containing products for preventing dental caries in children and adults. Cochrane Database Syst Rev. 2015 Mar 26;2015(3):CD010743. doi: 10.1002/14651858.CD010743.pub2.
PubMed 25809586Sakallioglu O, Guvenc IA, Cingi C. Xylitol and its usage in ENT practice. J Laryngol Otol. 2014 Jul;128(7):580-5. doi: 10.1017/S0022215114001340. Epub 2014 Jul 7.
PubMed 24999540Shashy RG, Moore EJ, Weaver A. Prevalence of the chronic sinusitis diagnosis in Olmsted County, Minnesota. Arch Otolaryngol Head Neck Surg. 2004 Mar;130(3):320-3. doi: 10.1001/archotol.130.3.320.
PubMed 15023840Cryer J, Schipor I, Perloff JR, Palmer JN. Evidence of bacterial biofilms in human chronic sinusitis. ORL J Otorhinolaryngol Relat Spec. 2004;66(3):155-8. doi: 10.1159/000079994.
PubMed 15316237Antunes MB, Feldman MD, Cohen NA, Chiu AG. Dose-dependent effects of topical tobramycin in an animal model of Pseudomonas sinusitis. Am J Rhinol. 2007 Jul-Aug;21(4):423-7. doi: 10.2500/ajr.2007.21.3046.
PubMed 17882910Chiu AG, Antunes MB, Palmer JN, Cohen NA. Evaluation of the in vivo efficacy of topical tobramycin against Pseudomonas sinonasal biofilms. J Antimicrob Chemother. 2007 Jun;59(6):1130-4. doi: 10.1093/jac/dkm087. Epub 2007 Apr 3.
PubMed 17405780Brown CL, Graham SM, Cable BB, Ozer EA, Taft PJ, Zabner J. Xylitol enhances bacterial killing in the rabbit maxillary sinus. Laryngoscope. 2004 Nov;114(11):2021-4. doi: 10.1097/01.mlg.0000147939.90249.47.
PubMed 15510034Cain RB, Lal D. Update on the management of chronic rhinosinusitis. Infect Drug Resist. 2013;6:1-14. doi: 10.2147/IDR.S26134. Epub 2013 Jan 23.
PubMed 23378777Lin L, Tang X, Wei J, Dai F, Sun G. Xylitol nasal irrigation in the treatment of chronic rhinosinusitis. Am J Otolaryngol. 2017 Jul-Aug;38(4):383-389. doi: 10.1016/j.amjoto.2017.03.006. Epub 2017 Apr 4.
PubMed 28390807Weissman JD, Fernandez F, Hwang PH. Xylitol nasal irrigation in the management of chronic rhinosinusitis: a pilot study. Laryngoscope. 2011 Nov;121(11):2468-72. doi: 10.1002/lary.22176. Epub 2011 Oct 12.
PubMed 21994147Isogangas P, Makinen KK, Tiekso J, Alanen P. Long-term effect of xylitol chewing gum in the prevention of dental caries: a follow-up 5 years after termination of a prevention program. Caries Res. 1993;27(6):495-8. doi: 10.1159/000261587.
PubMed 8281565
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT03229551
- Acronym / sponsor ID
- 2017.317.B
- Conditions
- Chronic Rhinosinusitis, Rhinosinusitis, Sinusitis, Drain Sinus, Endoscopic Sinus Surgery, Biofilms
- Keywords
- chronic rhinosinusitis, chronically draining sinus, condemned sinus, post-endoscopic sinus surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Collaborators
- Tulane University School of Medicine
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 25 Jul 2017 (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 purpose of this investigation is to conduct a randomized controlled trial within a subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt biofilms and improve disease control. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields. Specifically, the investigators will be studying the effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.
Detailed description
Problem Statement:
The purpose of this investigation is to conduct a trial within a subgroup of difficult-to-treat patients with CRS. This difficult group of patients will have undergone an exhaustive surgical and medical treatment of CRS These patient often will be frustrated with the lack of improvement in their symptoms despite maximal medical and surgical therapy. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields.
Purpose of Study/Potential Impact:
The purpose of this investigation is to conduct a randomized controlled trial within a subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt biofilms and improve disease control. The effectiveness of topical surfactants is a research gap in treating CRS but has promising correlates in other medical fields.
Potential Benefits:
Topical xylitol could potentially decrease CRS symptoms, leading to improvements in patient quality of life. This decrease could potentially lead to fewer visits to primary care physicians/otolaryngologists. These could lead to less antibiotics, radiographs being obtained and unnecessary surgical procedures being performed, all of which could potentially reduce the burden of medical expenditure in the treatment of this disease.
Potential Risks:
Potential risks are minimal but include a sweet aftertaste in the mouth and burning in the nose; which have been reported in previous studies.
Hypothesis:
5% (wt/vol) Xylitol saline irrigation into the diseased paranasal sinus, as a part of a post-ESS refractory CRS management plan, will reduce biofilm formation in the sinus and result in symptomatic relief in affected patients.
General Design:
A prospective, randomized, double-blinded experimental design will be utilized. Patients will be randomized into the xylitol-saline treatment arm versus the control saline arm. Concurrent corticosteroid/antibiotic therapy will be utilized in both arms based on results of bacterial DNA sequencing. Patients will undergo weekly in-office irrigations for three weeks and will be evaluated one month and three months post-treatment. The postoperative care will be standardized across all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylitol | Experimental | Drug: XylitolThis arm will evaluate the effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention. |
| Control | Active comparator | Drug: SalineThis arm is the standard of care saline irrigation solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients above the age of 18
- History of chronic rhinosinusitis history who had undergone bilateral endoscopic sinus surgery to include at a minimum maxillary antrostomy and anterior ethmoidectomy.
- Continued chronic sinusitis that is refractory to medical therapy after surgical intervention
Key exclusion criteria (11 listed)
- Patients under age of 18
- Non-English speaking
- History of immunodeficiency disease
- Cystic fibrosis
- Primary ciliary dyskinesia
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 |
|---|---|---|
| XylitolTopical 5% Xylitol (wt/vol) diluted in saline nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently. | Drug | Xylitol |
| SalineSaline as a standard-of-care nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently. | Drug | Control |
Primary outcome
The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.
Time frame: 3 months
Bacterial DNA sequencing obtained via endoscopic swab will be performed pre-treatment to analyse the presence of biofims in the diseased sinus. This assay will be repeated from the same sinus post-treatment with 5% Xylitol (wt/vol) to evaluate if medical intervention decreases biofilm production in the diseased sinus.
4 secondary outcomes
Sino-Nasal Outcome Test-22 (SNOT-22)
Time frame: 3 months
Brief Smell Identification Test (BSIT)
Time frame: 3 months
Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol
Time frame: 3 months
Correlation of DNA seqeuncing results with conventional sinonasal cultures
Time frame: 3 months
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 7 Apr 2023.
- Background: PubMed 20470665Harvey RJ, Psaltis A, Schlosser RJ, Witterick IJ. Current concepts in topical therapy for chronic sinonasal disease. J Otolaryngol Head Neck Surg. 2010 Jun;39(3):217-31.
- Background: PubMed 21150431Al-Mutairi D, Kilty SJ. Bacterial biofilms and the pathophysiology of chronic rhinosinusitis. Curr Opin Allergy Clin Immunol. 2011 Feb;11(1):18-23. doi: 10.1097/ACI.0b013e3283423376.
- Background: PubMed 27903594Hoggard M, Wagner Mackenzie B, Jain R, Taylor MW, Biswas K, Douglas RG. Chronic Rhinosinusitis and the Evolving Understanding of Microbial Ecology in Chronic Inflammatory Mucosal Disease. Clin Microbiol Rev. 2017 Jan;30(1):321-348. doi: 10.1128/CMR.00060-16.
- Background: PubMed 23710951Rosen PL, Palmer JN, O'Malley BW Jr, Cohen NA. Surfactants in the management of rhinopathologies. Am J Rhinol Allergy. 2013 May-Jun;27(3):177-80. doi: 10.2500/ajra.2013.27.3873.
- Background: PubMed 25809586Riley P, Moore D, Ahmed F, Sharif MO, Worthington HV. Xylitol-containing products for preventing dental caries in children and adults. Cochrane Database Syst Rev. 2015 Mar 26;2015(3):CD010743. doi: 10.1002/14651858.CD010743.pub2.
- Background: PubMed 24999540Sakallioglu O, Guvenc IA, Cingi C. Xylitol and its usage in ENT practice. J Laryngol Otol. 2014 Jul;128(7):580-5. doi: 10.1017/S0022215114001340. Epub 2014 Jul 7.
- Results publication: PubMed 15023840Shashy RG, Moore EJ, Weaver A. Prevalence of the chronic sinusitis diagnosis in Olmsted County, Minnesota. Arch Otolaryngol Head Neck Surg. 2004 Mar;130(3):320-3. doi: 10.1001/archotol.130.3.320.
- Results publication: PubMed 15316237Cryer J, Schipor I, Perloff JR, Palmer JN. Evidence of bacterial biofilms in human chronic sinusitis. ORL J Otorhinolaryngol Relat Spec. 2004;66(3):155-8. doi: 10.1159/000079994.
- Results publication: PubMed 17882910Antunes MB, Feldman MD, Cohen NA, Chiu AG. Dose-dependent effects of topical tobramycin in an animal model of Pseudomonas sinusitis. Am J Rhinol. 2007 Jul-Aug;21(4):423-7. doi: 10.2500/ajr.2007.21.3046.
- Results publication: PubMed 17405780Chiu AG, Antunes MB, Palmer JN, Cohen NA. Evaluation of the in vivo efficacy of topical tobramycin against Pseudomonas sinonasal biofilms. J Antimicrob Chemother. 2007 Jun;59(6):1130-4. doi: 10.1093/jac/dkm087. Epub 2007 Apr 3.
- Results publication: PubMed 15510034Brown CL, Graham SM, Cable BB, Ozer EA, Taft PJ, Zabner J. Xylitol enhances bacterial killing in the rabbit maxillary sinus. Laryngoscope. 2004 Nov;114(11):2021-4. doi: 10.1097/01.mlg.0000147939.90249.47.
- Results publication: PubMed 23378777Cain RB, Lal D. Update on the management of chronic rhinosinusitis. Infect Drug Resist. 2013;6:1-14. doi: 10.2147/IDR.S26134. Epub 2013 Jan 23.
- Individual participant dataSharing planned: No. Data will be presented in either a paper or electronic format. Upon its arrival, it will immediately be de-identified. If presented in a paper format, it will immediately be transferred into an electronic database. Only key personnel will have access to this data. The data will be encrypted and stored on permanent hardware or within the Ochsner secure network on a password-protected workstation.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Xylitol and Saline in people with Chronic Rhinosinusitis and Rhinosinusitis, run by Ochsner Health System 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 3 inclusion and 11 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 7 Apr 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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 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?
The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention. (time frame: 3 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 NCT03229551, which also lists 18 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 7 Apr 2023.