Oral Allergic SyndromeRAAPNCT04116580
Efficacy of Oral Tolerance Induction to Raw Apple
An observational study of Oral Allergic Syndrome and Allergic Reaction Caused by Food (Disorder), run by Michel Bouvier.
Trial summary
The aim of the study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Oral Allergic Syndrome, Allergic Reaction Caused by Food (Disorder)
- What is being tested?
- RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocol
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Oct 2018
- Phase
- Observational
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Food-Pollen Allergic patients aged 10 years and more, allergic to birch pollen and not eating any more rosacee for at least 6 months
Who may be able to join
- No longer eat raw rosacea for at least 6 months due to oral allergic syndrome
- With allergic rhinitis or asthma due to betulaceae pollen (SPT+ and/or IgE + to Bet v 1 > 0,10 kUA/L)
- With reduced quality of life
Who cannot join
- With severe allergic reaction to rosacea (>Grade 3 according to Ring and Messmer's classification)
- Pregnant woman
- Uncontrolled asthma (FEV1 < 70%)
- Immunosuppressed patient or having malignant disease, current infectious disease, or serious cardiovascular disease
- Opposed to use data
About this study
Official title: Efficacy of Oral Tolerance Induction to Raw Apple Using an Ultra Rush Protocol in 28 Rosacea Allergic Patients
The aim of the study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017.
Read the detailed description
The aim of this study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017.
Methods : Patients were included during the first consultation, UR was performed with RGA in day hospital performed in two institutions, the Charcot clinic and the polyclinic of Beaujolais.
Starting with 1 gram (g) of food, then by regularly doubling dose from 2g to 128g, to reach a 255g cumulative dose in a 3 hour period.
During the the post hospitalization period, patients back home had to eat ½ RGA a day during one month, then 1 RGA a day during one month, together with other rosacea fruits resumption at the end of the 5th week if UR were performed between April 15th and July 15th. A synthesis consultation was made at two months and a telephone interview at one year.
- Being tested
- RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocol
- Keywords
- Food Allergy, Apple Allergy, Oral Allergic Syndrome, Ultra-Rush, Tolerance induction, Cross-Allergy
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocolOther
| Study group | Role | What they receive |
|---|---|---|
| Allergic patients to raw apple and birch | Single-group studies about 28 patients allergic to birch and no longer eating raw rosaceae for at least 6 months. Patients brought back into contact with this family of fruits via the raw golden apple according to an Ultra-Rush protocol. Receives: Other: RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS)
Evaluation of the patients' tolerance to apple re-consumption was made during the ultra-rush protocol according to a scale inspired by the Hansen et al. classification, but the VAS used was graduated from 0 to 10 (and not from 0 to 3). This scale was enhanced with a three-color rule: the scale measured 3 levels of Oral Allergic Syndrome (OAS) severity: with no or mild side effects associated with the green color (0 to 3 on the scale), with moderate side effect associated with the orange color (4 to 6 on the scale) defined as moderate OAS (limited to oral cavity), and with severe side effect associated with red color (7 to 10 on the scale) defined as severe OAS (oral cavity together with systemic symptoms).
Green color corresponds to good tolerability, orange color to mixed results, and red color is correlated to poor tolerability.
Measured: [Time Frame: Day 1]
Secondary outcomes (8)
Ultra-Rush incidence on blood pressure constants (in mmHg)
Measurement of blood pressure constants during Ultra-Rush
Measured: [Time Frame: Day 1]
Ultra-Rush incidence on pulse rate (in bpm)
Measurement of pulse in beats per minute during Ultra-Rush
Measured: [Time Frame: Day 1]
Ultra-Rush incidence on peak-flow (in liters/mn)
Measurement of peak-flow in liters per minute during Ultra-Rush
Measured: [Time Frame: Day 1]
Procedure's safety on side effects according to a Visual Analogue Scale (VAS)
Measurement of side effects during Ultra-Rush (UR) and for the next two months according to the Visual Analogue Scale (VAS) used for the study.
The 0-10 graduated scale was enhanced with a three-color rule: the scale measured 3 levels of Oral Allergic Syndrome (OAS) severity: with no or mild side effects (green color), with moderate side effect (orange color), and with severe side effect (red color).
During UR, side effects intensity was evaluated on the VAS at each UR step. After UR and for the next two months, patients recorded daily the side effects on a notebook, using the same tool. These records were transcribed in the patients medical file by investigator.
Measured: [Time Frame: Day 1]
Tolerance of apple re-consumption on a daily basis during the 2 months following ultra-rush
Evaluation of the tolerance by means of visual scale with 3 levels of stringency: without side effects (associated with the green color), with moderate side effect (associated with the orange color) and with severe side effect (associated with red color)
Measured: [Time Frame: Day 1]
Tolerance of apple and other raw rosacea re-consumption two months post- Ultra-Rush for patients treated between mid-April and mid-July, according to a Visual Analogue Scale (VAS)
Tolerance was evaluated at the two months post Ultra-Rush visit, using the VAS. The 0-10 graduated scale was enhanced with a three-color rule: the scale measured 3 levels of Oral Allergic Syndrome (OAS) severity: with no or mild side effects (green color), with moderate side effect (orange color), and with severe side effect (red color).
Measured: [Time Frame: Day 1]
Number of participants eating rosacea with no or mild OAS at 1 year
During a specific interrogation in a telephone interview
Measured: [Time Frame: Day 1]
Biological sensitization profile of patients included
With an initial biological assessment to measure specific: Immunoglobulin E (IgE) apple; rBet v 1 (PR 10 protein); rBet v 2 (profilin protein) et rPru p 3 (lipid transfer protein)
Measured: [Time Frame: Day 1]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Jun 2016
- Primary completion31 Oct 2017
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Oral Allergic SyndromeStudies 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
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michel Bouvier
- Sponsor type
- Research network
- Collaborators
- Polyclinique du Beaujolais, Clinique Charcot
- Responsible party
- Sponsor-investigator, Michel Bouvier, Centre d'Allergologie du Beaujolais
- Investigators
- Bouvier Michel, MD, Principal investigator, Centre d' Allergologie du Beaujolais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116580
- Sponsor's protocol ID
- Apple CAB 1 - 2019
- Acronym
- RAAP
- Status last verified
- Oct 2019
- First submitted
- 11 Aug 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nucera E, Aruanno A, Lombardo C, Patriarca G, Schiavino D. Apple desensitization in two patients with PR-10 proteins allergy. Allergy. 2010 Aug;65(8):1060-1. doi: 10.1111/j.1398-9995.2009.02275.x. Epub 2009 Dec 3. No abstract available.
PubMed 19958318Kopac P, Rudin M, Gentinetta T, Gerber R, Pichler Ch, Hausmann O, Schnyder B, Pichler WJ. Continuous apple consumption induces oral tolerance in birch-pollen-associated apple allergy. Allergy. 2012 Feb;67(2):280-5. doi: 10.1111/j.1398-9995.2011.02744.x. Epub 2011 Nov 10.
PubMed 22070352Werfel T, Asero R, Ballmer-Weber BK, Beyer K, Enrique E, Knulst AC, Mari A, Muraro A, Ollert M, Poulsen LK, Vieths S, Worm M, Hoffmann-Sommergruber K. Position paper of the EAACI: food allergy due to immunological cross-reactions with common inhalant allergens. Allergy. 2015 Sep;70(9):1079-90. doi: 10.1111/all.12666. Epub 2015 Jul 7.
PubMed 26095197Bouvier M; Van der Brempt X; Nosbaum A; Cordier JM; Nicolas JF; Berard F. Induction of oral tolerance in allergy to rosaceae. Revue Française d'Allergologie (54): 127-133, 2014
Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
PubMed 24909706Mauro M, Russello M, Incorvaia C, Gazzola G, Frati F, Moingeon P, Passalacqua G. Birch-apple syndrome treated with birch pollen immunotherapy. Int Arch Allergy Immunol. 2011;156(4):416-22. doi: 10.1159/000323909. Epub 2011 Aug 10.
PubMed 21832831Incorvaia C, Ridolo E, Mauro M, Russello M, Pastorello E. Allergen immunotherapy for birch-apple syndrome: what do we know? Immunotherapy. 2017 Nov;9(15):1271-1278. doi: 10.2217/imt-2017-0040.
PubMed 29130794Hansen KS, Khinchi MS, Skov PS, Bindslev-Jensen C, Poulsen LK, Malling HJ. Food allergy to apple and specific immunotherapy with birch pollen. Mol Nutr Food Res. 2004 Nov;48(6):441-8. doi: 10.1002/mnfr.200400037.
PubMed 15508179Kinaciyan T, Jahn-Schmid B, Radakovics A, Zwolfer B, Schreiber C, Francis JN, Ebner C, Bohle B. Successful sublingual immunotherapy with birch pollen has limited effects on concomitant food allergy to apple and the immune response to the Bet v 1 homolog Mal d 1. J Allergy Clin Immunol. 2007 Apr;119(4):937-43. doi: 10.1016/j.jaci.2006.11.010. Epub 2007 Jan 3.
PubMed 17204315Scala E, Abeni D, Guerra EC, Locanto M, Pirrotta L, Meneguzzi G, Giani M, Asero R. Cosensitization to profilin is associated with less severe reactions to foods in nsLTPs and storage proteins reactors and with less severe respiratory allergy. Allergy. 2018 Sep;73(9):1921-1923. doi: 10.1111/all.13501. Epub 2018 Jun 22. No abstract available.
PubMed 29885248
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Tolerance Induction to Raw Apple Using an Ultra Rush Protocol in 28 Rosacea Allergic Patients
- ClinicalTrials.gov ID
- NCT04116580
- Acronym / sponsor ID
- RAAP / Apple CAB 1 - 2019
- Keywords
- Food Allergy, Apple Allergy, Oral Allergic Syndrome, Ultra-Rush, Tolerance induction, Cross-Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Michel BouvierResearch network
- Collaborators
- Polyclinique du Beaujolais, Clinique Charcot
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 4 Oct 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.
The aim of the study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017.
Detailed description
The aim of this study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017.
Methods : Patients were included during the first consultation, UR was performed with RGA in day hospital performed in two institutions, the Charcot clinic and the polyclinic of Beaujolais.
Starting with 1 gram (g) of food, then by regularly doubling dose from 2g to 128g, to reach a 255g cumulative dose in a 3 hour period.
During the the post hospitalization period, patients back home had to eat ½ RGA a day during one month, then 1 RGA a day during one month, together with other rosacea fruits resumption at the end of the 5th week if UR were performed between April 15th and July 15th. A synthesis consultation was made at two months and a telephone interview at one year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergic patients to raw apple and birch | – | Other: RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocolSingle-group studies about 28 patients allergic to birch and no longer eating raw rosaceae for at least 6 months. Patients brought back into contact with this family of fruits via the raw golden apple according to an Ultra-Rush protocol. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Food-Pollen Allergic patients aged 10 years and more, allergic to birch pollen and not eating any more rosacee for at least 6 months
Key inclusion criteria (3 listed)
- No longer eat raw rosacea for at least 6 months due to oral allergic syndrome
- With allergic rhinitis or asthma due to betulaceae pollen (SPT+ and/or IgE + to Bet v 1 > 0,10 kUA/L)
- With reduced quality of life
Key exclusion criteria (5 listed)
- With severe allergic reaction to rosacea (>Grade 3 according to Ring and Messmer's classification)
- Pregnant woman
- Uncontrolled asthma (FEV1 < 70%)
- Immunosuppressed patient or having malignant disease, current infectious disease, or serious cardiovascular disease
- Opposed to use data
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 |
|---|---|---|
| RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocol | Other | Allergic patients to raw apple and birch |
Primary outcome
Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS)
Time frame: [Time Frame: Day 1]
Evaluation of the patients' tolerance to apple re-consumption was made during the ultra-rush protocol according to a scale inspired by the Hansen et al. classification, but the VAS used was graduated from 0 to 10 (and not from 0 to 3). This scale was enhanced with a three-color rule: the scale measured 3 levels of Oral Allergic Syndrome (OAS) severity: with no or mild side effects associated with the green color (0 to 3 on the scale), with moderate side effect associated with the orange color (4 to 6 on the scale) defined as moderate OAS (limited to oral cavity), and with severe side effect associated with red color (7 to 10 on the scale) defined as severe OAS (oral cavity together with systemic symptoms). Green color corresponds to good tolerability, orange color to mixed results, and red color is correlated to poor tolerability.
8 secondary outcomes
Ultra-Rush incidence on blood pressure constants (in mmHg)
Time frame: [Time Frame: Day 1]
Ultra-Rush incidence on pulse rate (in bpm)
Time frame: [Time Frame: Day 1]
Ultra-Rush incidence on peak-flow (in liters/mn)
Time frame: [Time Frame: Day 1]
Procedure's safety on side effects according to a Visual Analogue Scale (VAS)
Time frame: [Time Frame: Day 1]
Tolerance of apple re-consumption on a daily basis during the 2 months following ultra-rush
Time frame: [Time Frame: Day 1]
Tolerance of apple and other raw rosacea re-consumption two months post- Ultra-Rush for patients treated between mid-April and mid-July, according to a Visual Analogue Scale (VAS)
Time frame: [Time Frame: Day 1]
Number of participants eating rosacea with no or mild OAS at 1 year
Time frame: [Time Frame: Day 1]
Biological sensitization profile of patients included
Time frame: [Time Frame: Day 1]
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 8 Oct 2019.
- Background: PubMed 19958318Nucera E, Aruanno A, Lombardo C, Patriarca G, Schiavino D. Apple desensitization in two patients with PR-10 proteins allergy. Allergy. 2010 Aug;65(8):1060-1. doi: 10.1111/j.1398-9995.2009.02275.x. Epub 2009 Dec 3. No abstract available.
- Background: PubMed 22070352Kopac P, Rudin M, Gentinetta T, Gerber R, Pichler Ch, Hausmann O, Schnyder B, Pichler WJ. Continuous apple consumption induces oral tolerance in birch-pollen-associated apple allergy. Allergy. 2012 Feb;67(2):280-5. doi: 10.1111/j.1398-9995.2011.02744.x. Epub 2011 Nov 10.
- Background: PubMed 26095197Werfel T, Asero R, Ballmer-Weber BK, Beyer K, Enrique E, Knulst AC, Mari A, Muraro A, Ollert M, Poulsen LK, Vieths S, Worm M, Hoffmann-Sommergruber K. Position paper of the EAACI: food allergy due to immunological cross-reactions with common inhalant allergens. Allergy. 2015 Sep;70(9):1079-90. doi: 10.1111/all.12666. Epub 2015 Jul 7.
- BackgroundBouvier M; Van der Brempt X; Nosbaum A; Cordier JM; Nicolas JF; Berard F. Induction of oral tolerance in allergy to rosaceae. Revue Française d'Allergologie (54): 127-133, 2014
- Background: PubMed 24909706Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
- Background: PubMed 21832831Mauro M, Russello M, Incorvaia C, Gazzola G, Frati F, Moingeon P, Passalacqua G. Birch-apple syndrome treated with birch pollen immunotherapy. Int Arch Allergy Immunol. 2011;156(4):416-22. doi: 10.1159/000323909. Epub 2011 Aug 10.
- Background: PubMed 29130794Incorvaia C, Ridolo E, Mauro M, Russello M, Pastorello E. Allergen immunotherapy for birch-apple syndrome: what do we know? Immunotherapy. 2017 Nov;9(15):1271-1278. doi: 10.2217/imt-2017-0040.
- Background: PubMed 15508179Hansen KS, Khinchi MS, Skov PS, Bindslev-Jensen C, Poulsen LK, Malling HJ. Food allergy to apple and specific immunotherapy with birch pollen. Mol Nutr Food Res. 2004 Nov;48(6):441-8. doi: 10.1002/mnfr.200400037.
- Background: PubMed 17204315Kinaciyan T, Jahn-Schmid B, Radakovics A, Zwolfer B, Schreiber C, Francis JN, Ebner C, Bohle B. Successful sublingual immunotherapy with birch pollen has limited effects on concomitant food allergy to apple and the immune response to the Bet v 1 homolog Mal d 1. J Allergy Clin Immunol. 2007 Apr;119(4):937-43. doi: 10.1016/j.jaci.2006.11.010. Epub 2007 Jan 3.
- Background: PubMed 29885248Scala E, Abeni D, Guerra EC, Locanto M, Pirrotta L, Meneguzzi G, Giani M, Asero R. Cosensitization to profilin is associated with less severe reactions to foods in nsLTPs and storage proteins reactors and with less severe respiratory allergy. Allergy. 2018 Sep;73(9):1921-1923. doi: 10.1111/all.13501. Epub 2018 Jun 22. No abstract available.
- 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. This study is not recruiting at the moment.
Bouvier Michel, MD principal investigator
Centre d' Allergologie du Beaujolais
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Allergic Syndrome and Allergic Reaction Caused by Food (Disorder), run by Michel Bouvier.
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 5 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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?
Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS) (time frame: [Time Frame: Day 1]). 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 NCT04116580, which also lists 10 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 8 Oct 2019.