Eosinophilic EsophagitisNCT05309590
Efficacy of Low-Dose Topical Steroids in Maintaining Remission of Eosinophilic Esophagitis in Children
An observational study of Eosinophilic Esophagitis, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This study evaluates the decrease in steroid dosing for patients who have achieved remission on a full dose of steroids. Once a patient is in remission they will be enrolled in this study if they choose to decrease the steroid dosing. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Dose
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Nov 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 1 year to 21 years
- All sexes
- Child, Adult
Study population: By design, this study involves the participation of children. It is not anticipated that any other special groups be enrolled in a proportion other than that representative of the US population. Enrollment will not be limited by race or gender.
Who may be able to join
- Patients diagnosed with EoE
- Patients less than 21 years of age at enrollment
- Patients who within the past 12 months have demonstrated histologic remission (<15 eos/hpf as assessed by upper esophagogastroduodenoscopy (EGD) with biopsy ) to the standard induction dose of topical steroids and have remained on this treatment:
- Topical steroid treatment includes only those with previously published results: Swallowed topical fluticasone (i.e. Flovent®), and Swallowed viscous budesonide (i.e. Pulmicort Respules®) mixed with Honey or Splenda®
- Patients who are interested in lowering their dose of topical steroids.
Who cannot join
- Patients with EoE who have not demonstrated histologic remission (<15 eos/hpf) to topical steroids.
- Patients who are unable or unwilling to take topical steroids.
- Patients who have changed the vehicle or carrier (e.g. Splenda®or honey ) used to mix with the actual steroid drug, after demonstrating histologic remission.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Childjren's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Prospective Pilot Study Evaluating the Efficacy of Low-Dose Topical Steroids in Maintaining Histologic Remission of Eosinophilic Esophagitis in Children
This study evaluates the decrease in steroid dosing for patients who have achieved remission on a full dose of steroids. Once a patient is in remission they will be enrolled in this study if they choose to decrease the steroid dosing.
Read the detailed description
As the disease usually recurs once steroids are discontinued, and there is concern for complications of untreated disease, continuation of steroids is indefinite after induction of remission. The short-term safety of topical steroids has been well established; however, long-term safety has not been studied in EoE. Concerns for long-term complications of chronic steroid therapy include effects on bone density and stature as has been suggested by literature in patients with asthma treated with inhaled corticosteroids chronically.4, 5 It remains unclear whether symptom and histologic remission, once achieved, can be maintained with a lower, to be defined, dosage of topical steroids.6 This is critical to prevent the major complications associated with uncontrolled eosinophilic inflammation: fibrotic remodeling (scarring) of the esophagus and eventual stricture (narrowing of the esophagus).7-11
Several studies have demonstrated that remission with induction (approximately 3 months of therapy) dose topical steroids resulted in resolution of inflammation and concurrent reversal of sub-epithelial early-stage fibrosis.12-18 It has not, however, been established whether fibrosis recurs when patients are maintained on induction doses long-term or whether lower "maintenance" dosing is sufficient. Studies are therefore needed to demonstrate whether fibrosis can be prevented from recurring long-term, ideally at a lower maintenance dose to minimize potential complications of therapy. Therapeutic strategies that achieve continuous and sustained remission with resolution of eosinophilic inflammation will prevent chronic symptoms along with remodeling, fibrosis and eventual esophageal stricture.
The rationale for utilizing lower dose topical steroids for maintaining clinical and histologic remission in children is the potential to lower the steroid-related side effects including contracting oral and/or esophageal fungal infections (a yeast infection which causes white patches in the mouth and throat), loss of bone density, suppression of adrenal-cortical axis (turns off the body's usual production of cortisol, which helps the body maintain a balance and respond to stress), and failure to achieve linear growth (height) potential. There are no studies that have properly quantified the risk of swallowed steroids in EoE, thus the investigators are presuming and postulating a lower cumulative risk of adverse effects from long-term use of the medication with this lower dose than the standard dose.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Dose
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoseDrug
The outcomes of reducing to half of the topical steroid (i.e. fluticasone [Flovent] and Swallowed viscous budesonide [Pulmicort]) will be observed with regards to whether the patients continue to be in histologic remission. These patients will have already achieved remission on a full dose of the steroid.
| Study group | Role | What they receive |
|---|---|---|
| Dose Reduction | All patients recruited to the study will have reduced their swallowed steroid medication from twice to once daily as part of the standard-of-care. Receives: Drug: Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Low Dose Topical Steroid
Number of patients who maintain histologic remission of low dose (50% dosing) topical steroids
Measured: At standard of care endoscopies from the date of enrollment; estimated every 6-12 months
Secondary outcomes (1)
Visual and histologic assessment of the esophagus
assess the change in visual findings on steroid or half dose steroid and whether patients were able to maintain visual and histologic remission when on low dose (50% dosing) topical steroids
Measured: At standard of care endoscopies from the date of enrollment; estimated every 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study startMay 2014
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Wechsler, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Joshua B Wechsler, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309590
- Sponsor's protocol ID
- 2014-15753
- Other IDs
- 2014
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schoepfer AM, Safroneeva E, Bussmann C, Kuchen T, Portmann S, Simon HU, Straumann A. Delay in diagnosis of eosinophilic esophagitis increases risk for stricture formation in a time-dependent manner. Gastroenterology. 2013 Dec;145(6):1230-6.e1-2. doi: 10.1053/j.gastro.2013.08.015. Epub 2013 Aug 13.
PubMed 23954315Dellon ES, Kim HP, Sperry SL, Rybnicek DA, Woosley JT, Shaheen NJ. A phenotypic analysis shows that eosinophilic esophagitis is a progressive fibrostenotic disease. Gastrointest Endosc. 2014 Apr;79(4):577-85.e4. doi: 10.1016/j.gie.2013.10.027. Epub 2013 Nov 23.
PubMed 24275329Papadopoulou A, Koletzko S, Heuschkel R, Dias JA, Allen KJ, Murch SH, Chong S, Gottrand F, Husby S, Lionetti P, Mearin ML, Ruemmele FM, Schappi MG, Staiano A, Wilschanski M, Vandenplas Y; ESPGHAN Eosinophilic Esophagitis Working Group and the Gastroenterology Committee. Management guidelines of eosinophilic esophagitis in childhood. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):107-18. doi: 10.1097/MPG.0b013e3182a80be1.
PubMed 24378521Weldon D. The effects of corticosteroids on bone growth and bone density. Ann Allergy Asthma Immunol. 2009 Jul;103(1):3-11; quiz 11-3, 50. doi: 10.1016/S1081-1206(10)60135-4.
PubMed 19663120de Vreede I, Haarman EG, Sprikkelman AB, van Aalderen WM. From knemometry to final adult height: inhaled corticosteroids and their effect on growth in childhood. Paediatr Respir Rev. 2013 Jun;14(2):107-11; quiz 111, 137-8. doi: 10.1016/j.prrv.2012.05.001. Epub 2012 Jun 9.
PubMed 23718991Liacouras CA, Furuta GT, Hirano I, Atkins D, Attwood SE, Bonis PA, Burks AW, Chehade M, Collins MH, Dellon ES, Dohil R, Falk GW, Gonsalves N, Gupta SK, Katzka DA, Lucendo AJ, Markowitz JE, Noel RJ, Odze RD, Putnam PE, Richter JE, Romero Y, Ruchelli E, Sampson HA, Schoepfer A, Shaheen NJ, Sicherer SH, Spechler S, Spergel JM, Straumann A, Wershil BK, Rothenberg ME, Aceves SS. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol. 2011 Jul;128(1):3-20.e6; quiz 21-2. doi: 10.1016/j.jaci.2011.02.040. Epub 2011 Apr 7.
PubMed 21477849Straumann A, Bussmann C, Zuber M, Vannini S, Simon HU, Schoepfer A. Eosinophilic esophagitis: analysis of food impaction and perforation in 251 adolescent and adult patients. Clin Gastroenterol Hepatol. 2008 May;6(5):598-600. doi: 10.1016/j.cgh.2008.02.003. Epub 2008 Apr 14.
PubMed 18407800Fox VL, Nurko S, Teitelbaum JE, Badizadegan K, Furuta GT. High-resolution EUS in children with eosinophilic "allergic" esophagitis. Gastrointest Endosc. 2003 Jan;57(1):30-6. doi: 10.1067/mge.2003.33.
PubMed 12518127Kwiatek MA, Hirano I, Kahrilas PJ, Rothe J, Luger D, Pandolfino JE. Mechanical properties of the esophagus in eosinophilic esophagitis. Gastroenterology. 2011 Jan;140(1):82-90. doi: 10.1053/j.gastro.2010.09.037. Epub 2010 Sep 19.
PubMed 20858491Chehade M, Sampson HA, Morotti RA, Magid MS. Esophageal subepithelial fibrosis in children with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2007 Sep;45(3):319-28. doi: 10.1097/MPG.0b013e31806ab384.
PubMed 17873744Aceves SS, Newbury RO, Dohil R, Bastian JF, Broide DH. Esophageal remodeling in pediatric eosinophilic esophagitis. J Allergy Clin Immunol. 2007 Jan;119(1):206-12. doi: 10.1016/j.jaci.2006.10.016.
PubMed 17208603Wagener JS, Wojtczak HA. Inhaled steroids in children: risks versus rewards. J Pediatr. 1998 Mar;132(3 Pt 1):381-3. doi: 10.1016/s0022-3476(98)70003-4. No abstract available.
PubMed 9544884Aceves SS, Bastian JF, Newbury RO, Dohil R. Oral viscous budesonide: a potential new therapy for eosinophilic esophagitis in children. Am J Gastroenterol. 2007 Oct;102(10):2271-9; quiz 2280. doi: 10.1111/j.1572-0241.2007.01379.x. Epub 2007 Jun 20.
PubMed 17581266Straumann A, Degen L, Felder S, et al. Budesonide As Induction Treatment for Active Eosinophilic Esophagitis In Adolescents and Adults: A Randomized, Double-Blind, Placebo-Controlled Study (Bee-I Trial). Gastroenterology 2008;134:A-104.
Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.
PubMed 20457157
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study Evaluating the Efficacy of Low-Dose Topical Steroids in Maintaining Histologic Remission of Eosinophilic Esophagitis in Children
- ClinicalTrials.gov ID
- NCT05309590
- Acronym / sponsor ID
- 2014-15753
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the decrease in steroid dosing for patients who have achieved remission on a full dose of steroids. Once a patient is in remission they will be enrolled in this study if they choose to decrease the steroid dosing.
Detailed description
As the disease usually recurs once steroids are discontinued, and there is concern for complications of untreated disease, continuation of steroids is indefinite after induction of remission. The short-term safety of topical steroids has been well established; however, long-term safety has not been studied in EoE. Concerns for long-term complications of chronic steroid therapy include effects on bone density and stature as has been suggested by literature in patients with asthma treated with inhaled corticosteroids chronically.4, 5 It remains unclear whether symptom and histologic remission, once achieved, can be maintained with a lower, to be defined, dosage of topical steroids.6 This is critical to prevent the major complications associated with uncontrolled eosinophilic inflammation: fibrotic remodeling (scarring) of the esophagus and eventual stricture (narrowing of the esophagus).7-11
Several studies have demonstrated that remission with induction (approximately 3 months of therapy) dose topical steroids resulted in resolution of inflammation and concurrent reversal of sub-epithelial early-stage fibrosis.12-18 It has not, however, been established whether fibrosis recurs when patients are maintained on induction doses long-term or whether lower "maintenance" dosing is sufficient. Studies are therefore needed to demonstrate whether fibrosis can be prevented from recurring long-term, ideally at a lower maintenance dose to minimize potential complications of therapy. Therapeutic strategies that achieve continuous and sustained remission with resolution of eosinophilic inflammation will prevent chronic symptoms along with remodeling, fibrosis and eventual esophageal stricture.
The rationale for utilizing lower dose topical steroids for maintaining clinical and histologic remission in children is the potential to lower the steroid-related side effects including contracting oral and/or esophageal fungal infections (a yeast infection which causes white patches in the mouth and throat), loss of bone density, suppression of adrenal-cortical axis (turns off the body's usual production of cortisol, which helps the body maintain a balance and respond to stress), and failure to achieve linear growth (height) potential. There are no studies that have properly quantified the risk of swallowed steroids in EoE, thus the investigators are presuming and postulating a lower cumulative risk of adverse effects from long-term use of the medication with this lower dose than the standard dose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Reduction | – | Drug: DoseAll patients recruited to the study will have reduced their swallowed steroid medication from twice to once daily as part of the standard-of-care. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- By design, this study involves the participation of children. It is not anticipated that any other special groups be enrolled in a proportion other than that representative of the US population. Enrollment will not be limited by race or gender.
Key inclusion criteria (5 listed)
- Patients diagnosed with EoE
- Patients less than 21 years of age at enrollment
- Patients who within the past 12 months have demonstrated histologic remission (<15 eos/hpf as assessed by upper esophagogastroduodenoscopy (EGD) with biopsy ) to the standard induction dose of topical steroids and have remained on this treatment:
- Patients who are interested in lowering their dose of topical steroids.
Key exclusion criteria (3 listed)
- Patients with EoE who have not demonstrated histologic remission (<15 eos/hpf) to topical steroids.
- Patients who are unable or unwilling to take topical steroids.
- Patients who have changed the vehicle or carrier (e.g. Splenda®or honey ) used to mix with the actual steroid drug, after demonstrating histologic remission.
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 |
|---|---|---|
| DoseThe outcomes of reducing to half of the topical steroid (i.e. fluticasone [Flovent] and Swallowed viscous budesonide [Pulmicort]) will be observed with regards to whether the patients continue to be in histologic remission. These patients will have already achieved remission on a full dose of the steroid. | Drug | Dose Reduction |
Primary outcome
Efficacy of Low Dose Topical Steroid
Time frame: At standard of care endoscopies from the date of enrollment; estimated every 6-12 months
Number of patients who maintain histologic remission of low dose (50% dosing) topical steroids
1 secondary outcome
Visual and histologic assessment of the esophagus
Time frame: At standard of care endoscopies from the date of enrollment; estimated every 6-12 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 17 Mar 2026.
- Background: PubMed 23954315Schoepfer AM, Safroneeva E, Bussmann C, Kuchen T, Portmann S, Simon HU, Straumann A. Delay in diagnosis of eosinophilic esophagitis increases risk for stricture formation in a time-dependent manner. Gastroenterology. 2013 Dec;145(6):1230-6.e1-2. doi: 10.1053/j.gastro.2013.08.015. Epub 2013 Aug 13.
- Background: PubMed 24275329Dellon ES, Kim HP, Sperry SL, Rybnicek DA, Woosley JT, Shaheen NJ. A phenotypic analysis shows that eosinophilic esophagitis is a progressive fibrostenotic disease. Gastrointest Endosc. 2014 Apr;79(4):577-85.e4. doi: 10.1016/j.gie.2013.10.027. Epub 2013 Nov 23.
- Background: PubMed 24378521Papadopoulou A, Koletzko S, Heuschkel R, Dias JA, Allen KJ, Murch SH, Chong S, Gottrand F, Husby S, Lionetti P, Mearin ML, Ruemmele FM, Schappi MG, Staiano A, Wilschanski M, Vandenplas Y; ESPGHAN Eosinophilic Esophagitis Working Group and the Gastroenterology Committee. Management guidelines of eosinophilic esophagitis in childhood. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):107-18. doi: 10.1097/MPG.0b013e3182a80be1.
- Background: PubMed 19663120Weldon D. The effects of corticosteroids on bone growth and bone density. Ann Allergy Asthma Immunol. 2009 Jul;103(1):3-11; quiz 11-3, 50. doi: 10.1016/S1081-1206(10)60135-4.
- Background: PubMed 23718991de Vreede I, Haarman EG, Sprikkelman AB, van Aalderen WM. From knemometry to final adult height: inhaled corticosteroids and their effect on growth in childhood. Paediatr Respir Rev. 2013 Jun;14(2):107-11; quiz 111, 137-8. doi: 10.1016/j.prrv.2012.05.001. Epub 2012 Jun 9.
- Background: PubMed 21477849Liacouras CA, Furuta GT, Hirano I, Atkins D, Attwood SE, Bonis PA, Burks AW, Chehade M, Collins MH, Dellon ES, Dohil R, Falk GW, Gonsalves N, Gupta SK, Katzka DA, Lucendo AJ, Markowitz JE, Noel RJ, Odze RD, Putnam PE, Richter JE, Romero Y, Ruchelli E, Sampson HA, Schoepfer A, Shaheen NJ, Sicherer SH, Spechler S, Spergel JM, Straumann A, Wershil BK, Rothenberg ME, Aceves SS. Eosinophilic esophagitis: updated consensus recommendations for children and adults. J Allergy Clin Immunol. 2011 Jul;128(1):3-20.e6; quiz 21-2. doi: 10.1016/j.jaci.2011.02.040. Epub 2011 Apr 7.
- Background: PubMed 18407800Straumann A, Bussmann C, Zuber M, Vannini S, Simon HU, Schoepfer A. Eosinophilic esophagitis: analysis of food impaction and perforation in 251 adolescent and adult patients. Clin Gastroenterol Hepatol. 2008 May;6(5):598-600. doi: 10.1016/j.cgh.2008.02.003. Epub 2008 Apr 14.
- Background: PubMed 12518127Fox VL, Nurko S, Teitelbaum JE, Badizadegan K, Furuta GT. High-resolution EUS in children with eosinophilic "allergic" esophagitis. Gastrointest Endosc. 2003 Jan;57(1):30-6. doi: 10.1067/mge.2003.33.
- Background: PubMed 20858491Kwiatek MA, Hirano I, Kahrilas PJ, Rothe J, Luger D, Pandolfino JE. Mechanical properties of the esophagus in eosinophilic esophagitis. Gastroenterology. 2011 Jan;140(1):82-90. doi: 10.1053/j.gastro.2010.09.037. Epub 2010 Sep 19.
- Background: PubMed 17873744Chehade M, Sampson HA, Morotti RA, Magid MS. Esophageal subepithelial fibrosis in children with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2007 Sep;45(3):319-28. doi: 10.1097/MPG.0b013e31806ab384.
- Background: PubMed 17208603Aceves SS, Newbury RO, Dohil R, Bastian JF, Broide DH. Esophageal remodeling in pediatric eosinophilic esophagitis. J Allergy Clin Immunol. 2007 Jan;119(1):206-12. doi: 10.1016/j.jaci.2006.10.016.
- Background: PubMed 9544884Wagener JS, Wojtczak HA. Inhaled steroids in children: risks versus rewards. J Pediatr. 1998 Mar;132(3 Pt 1):381-3. doi: 10.1016/s0022-3476(98)70003-4. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Joshua B Wechsler, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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?
Efficacy of Low Dose Topical Steroid (time frame: At standard of care endoscopies from the date of enrollment; estimated every 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 NCT05309590, which also lists 21 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 17 Mar 2026.