Pharmacological ActionsPhase 4iFAAM-PPINCT07902440
The Impact of Proton-pump Inhibitors on Threshold Dose Distributions
A Phase 4 study testing Omeprazol - Walnut and Manitol - Walnut in people with Pharmacological Actions, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Background and Rationale: Antacids might influence the structure/degradation and therefore the allergenicity of food proteins. This study intends to perform double-blind placebo-controlled food challenges in walnut allergic patient to determine threshold dose distribution curves and to investigate the impact of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacological Actions
- What is being tested?
- Omeprazol - Walnut and Manitol - Walnut
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Nov 2018
- Phase
- Phase 4
- 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
- Positive case history of immediate allergic reaction(s) to walnut
- Presence of specific IgE to walnut assessed by either SPT (≥ 3 mm mean wheal diameter) or serum IgE determination (≥ 0.35 kU/L) by ImmunoCAP (ThermoFisher Scientific, Uppsala, Sweden) in the previous 12 months.
- Informed Consent as documented by signature
Who cannot join
- Known hypersensitivity or allergy to Omeprazole or other PPI
- Known hypersensitivity or allergy to mannitol
- Drugs not allowed during the study due to proved interaction with Omeprazole: Digoxin, Clopidogrel, Methotrexate, Antiretroviral drugs, Diazepam, Cilostazol, Phenytoin, Warfarin (R-Warfarin) and other Vitamin K antagonists, Phenytoin, Tacrolimus, Drugs suppressing or inducing CYP2C19 or CYP3A4 such as Clarithromycin, Voriconazol, Rifampicin and Hypericum
- Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge)
- corticosteroids systemically (2 weeks)
- antihistamines (3 days) except hydroxizine (10 days)
Show all 25Show fewer
- ketotifen (2 weeks)
- betablocking agents (1 day)
- angiotensin converting enzyme (ACE) inhibitors (2 days)
- tricyclic antidepressants (5 days)
- omalizumab (2 months)
- immunosuppressive treatments
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices
- Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- Uncontrolled asthma, FEV1 <70% predicted value
- Acute allergic disease (transient exclusion criterium)
- Chronic urticaria
- Mastocytosis, elevated tryptase/mast clonal disorders
- A contraindication to adrenaline (i.e. ischaemic heart disease, poor controlled hypertension or cardiac arrhythmia)
- Other clinically significant concomitant disease states (major organic or infectious diseases, e.g., renal failure, hepatic dysfunction, cardiovascular disease, acute febrile infection, psychiatric disorders) that can affect patient's safety or can make the implementation of the protocol or the interpretation of results difficult.
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Proton-pump Inhibitors on the Threshold Dose Distribution in Walnut Allergy
Background and Rationale:
Antacids might influence the structure/degradation and therefore the allergenicity of food proteins. This study intends to perform double-blind placebo-controlled food challenges in walnut allergic patient to determine threshold dose distribution curves and to investigate the impact of antacids (proton-pump inhibitors) on the allergy eliciting dose of walnut and the severity of the clinical manifestation in walnut allergic patients.
Read more
Objectives:
Investigation of effect of Omeprazole on the threshold dose-distribution curve and the severity of the clinical manifestation of walnut allergic patients.
Outcomes:
Primary outcome Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole.
Study design:
Multicentre, randomised, placebo-controlled; cross-over design.
Selection criteria: positive case history of immediate allergic reaction(s) to walnut and presence of specific IgE to walnut defined as a positive (≥ 3 mm wheal diameter) skin prick test and/or a serum IgE to walnut ≥ 0.35 kU/L ( ImmunoCAP).
Measurements and procedures:
Skin-prick-testing with different extracts, blood sampling for immunological testing, double-blind placebo controlled food challenge with walnut with/without previous Omeprazole.
Intervention: Omeprazol versus placebo.
Number of Participants:
Two clinical centers will participate in this study, Madrid-Spain (ES) and Zürich-Switzerland (CH). The final study population for each center will consist of 30 subjects with a challenge confirmed walnut allergy. This sample size will allow to build the probabilistic models to determine threshold dose distribution curves of walnut and calculate the ED05 and ED10.
Read the detailed description
Background and Rationale:
Antacids might influence the structure/degradation and therefore the allergenicity of food proteins. This study intends to perform double-blind placebo-controlled food challenges in walnut allergic patient to determine threshold dose distribution curves and to investigate the impact of antacids (proton-pump inhibitors) on the allergy eliciting dose of walnut and the severity of the clinical manifestation in walnut allergic patients.
Objective(s):
Primary study objectives:
Investigation of effect of Omeprazole on the threshold dose-distribution curve and the severity of the clinical manifestation of walnut allergic patients.
Secondary study objectives:
Determination of minimal eliciting dose of walnut protein in walnut allergic patients Calculation of the dose of walnut protein leading to an allergic reaction in 5% (ED05) and 10% (ED10) of walnut allergic population Analyse differences in walnut threshold distributions curves and severity related to allergen sensitisation pattern and geographical location.
Outcome(s):
Primary outcome Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole.
Secondary outcome Determination of threshold dose-distribution curve in walnut allergy and calculation of the dose of walnut protein leading to allergic reactions in patients with confirmed food allergy to walnuts.
Study design:
Multicentre, randomised, placebo-controlled; cross-over design.
Selection criteria:
Key inclusion criteria
- positive case history of immediate allergic reaction(s) to walnut
- age ≥ 18 years
- presence of specific IgE to walnut defined as a positive (≥ 3 mm wheal diameter) skin prick test and/or a serum IgE to walnut ≥ 0.35 kU/L ( ImmunoCAP).
Key exclusion criteria
- intake of drugs interfering with Omeprazole or the allergic response under food challenge
- pregnancy, breastfeeding
- acute allergic disease
- any contraindication to adrenaline or to food challenge.
Measurements and procedures:
Skin-prick-testing with different extracts, blood sampling for immunological testing, double-blind placebo controlled food challenge with walnut with/without previous Omeprazole.
Study Product / Intervention:
Omeprazole: Omeprazole Sandoz capsules 40 mg® One treatment run of 5 days, 40 mg (1 capsule) per day
Control Intervention (if applicable):
Placebo capsules containing mannitol Two treatment runs of 5 days, 1 capsule per day
Number of Participants with Rationale:
Two clinical centers will participate in this study, Madrid-Spain (ES) and Zürich-Switzerland (CH). These two centers have been included because the allergens involved in walnut allergy differ, and this will allow to study geographical differences related to the allergen sensitization profile. In Spain patients are sensitized to stable walnut allergens such as lipid transfer proteins (LTP) and storage proteins, whereas in Switzerland patients allergic to walnut are sensitized to labile allergens homologous to Bet v 1.
The final study population for each center will consist of 30 subjects with a challenge confirmed walnut allergy. This sample size will allow to build the probabilistic models to determine threshold dose distribution curves of walnut and calculate the ED05 and ED10. At the same time a population of n=60 will allow to find differences between patients treated with omeprazol and placebo analysed by discrete time survival analysis, given that for a hazard ratio of 2.5, and an anticipated 30% of right censoring, with a confidence level of 95% (α=0.05) and a 90% statistical power (β=0.10) a sample size of 36 subjects is enough.
Due to our experience the investigators will have to include 60 patients at each site with a positive case history of walnut allergy undergoing food challenges to identify 30 patients at each site with a positive food challenge
Statistical Considerations:
The final study population for each center will consist of 30 subjects with a challenge confirmed walnut allergy. This sample size will allow to build the probabilistic models to determine threshold dose distribution curves of walnut and calculate the ED05 and ED10. At the same time a population of n=60 will allow to find differences between patients treated with omeprazol and placebo analysed by discrete time survival analysis, given that for a hazard ratio of 2.5, and an anticipated 30% of right censoring, with a confidence level of 95% (α=0.05) and a 90% statistical power (β=0.10) a sample size of 36 subjects is enough.
GCP Statement:
This study will be conducted according to the standards established by ICH-GCP, The Clinical Trials Directive (2001/20/EC), the Declaration of Helsinki and any applicable local laws. The study will require approval from the Local Ethics Committees and authorization from the National Medicines Agency in each country (AEMPS, Swissmedic) prior to initiation.
- Conditions
- Pharmacological Actions
- Being tested
- Omeprazol - Walnut, Manitol - Walnut, Manitol - Placebo Meal
- Keywords
- Walnut allergy, Omeprazole, Threshold dose, Food 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.
Omeprazol - WalnutDrug
Manitol - WalnutDrug
Manitol - Placebo MealDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Active Drug - Active Meal | Active comparator | One treatment run of 5 days of Omeprazol 40 mg (1 capsule) per day. In the fifth day patient will receive a walnut challenge set consists of 9 portions served at an interval of 20-30 minutes. Receives: Drug: Omeprazol - Walnut |
| Arma B: Placebo Drug - Active Meal | Placebo comparator | One treatment run of 5 days of Mannitol. In the fifth day patient will receive a walnut challenge set consists of 9 portions served at an interval of 20-30 minutes. Receives: Drug: Manitol - Walnut |
| Arm C: Placebo Drug - Placebo Meal | Placebo comparator | One treatment run of 5 days of Mannitol. In the fifth day patient will receive a placebo challenge set consists of 9 portions served at an interval of 20-30 minutes. Receives: Drug: Manitol - Placebo Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of walnut protein leading to allergic reactions in 5% (ED05)
Determination of threshold dose-distribution curve in walnut allergy and calculation of the dose of walnut protein leading to allergic reactions in 5% (ED05) patients with confirmed food allergy to walnuts.
Measured: 1.5-8.5 months
Secondary outcomes (2)
Dose of walnut protein leading to allergic reactions in 10% (ED10)
Porcentage of patients with confirmed food allergy to walnuts that reacts to the ED10.
Measured: 1.5-8.5 months
Determination of differences in threshold and severity related to allergen sensitization pattern and geographical location.
Determination of differences in threshold and severity related to allergen sensitization pattern and geographical location.
Measured: 1.5-8.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startApr 2016
- Primary completionJun 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Seventh Framework Programme
- Responsible party
- Principal investigator, Guadalupe Marco Martín, Hospital San Carlos, Madrid
- Investigators
- Montserrat Fernández-Rivas, MD, PhD, Principal investigator, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902440
- Sponsor's protocol ID
- 2015-001863-38
- Other IDs
- 2015
- Acronym
- iFAAM-PPI
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2016
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Proton-pump Inhibitors on the Threshold Dose Distribution in Walnut Allergy
- ClinicalTrials.gov ID
- NCT07902440
- Acronym / sponsor ID
- iFAAM-PPI / 2015-001863-38
- Conditions
- Pharmacological Actions
- Keywords
- Walnut allergy, Omeprazole, Threshold dose, Food allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Seventh Framework Programme
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 28 Oct 2026 (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.
Background and Rationale:
Antacids might influence the structure/degradation and therefore the allergenicity of food proteins. This study intends to perform double-blind placebo-controlled food challenges in walnut allergic patient to determine threshold dose distribution curves and to investigate the impact of antacids (proton-pump inhibitors) on the allergy eliciting dose of walnut and the severity of the clinical manifestation in walnut allergic patients.
Objectives:
Investigation of effect of Omeprazole on the threshold dose-distribution curve and the severity of the clinical manifestation of walnut allergic patients.
Outcomes:
Primary outcome Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole.
Study design:
Multicentre, randomised, placebo-controlled; cross-over design.
Selection criteria: positive case history of immediate allergic reaction(s) to walnut and presence of specific IgE to walnut defined as a positive (≥ 3 mm wheal diameter) skin prick test and/or a serum IgE to walnut ≥ 0.35 kU/L ( ImmunoCAP).
Measurements and procedures:
Skin-prick-testing with different extracts, blood sampling for immunological testing, double-blind placebo controlled food challenge with walnut with/without previous Omeprazole.
Intervention: Omeprazol versus placebo.
Number of Participants:
Two clinical centers will participate in this study, Madrid-Spain (ES) and Zürich-Switzerland (CH). The final study population for each center will consist of 30 subjects with a challenge confirmed walnut allergy. This sample size will allow to build the probabilistic models to determine threshold dose distribution curves of walnut and calculate the ED05 and ED10.
Detailed description
Background and Rationale:
Antacids might influence the structure/degradation and therefore the allergenicity of food proteins. This study intends to perform double-blind placebo-controlled food challenges in walnut allergic patient to determine threshold dose distribution curves and to investigate the impact of antacids (proton-pump inhibitors) on the allergy eliciting dose of walnut and the severity of the clinical manifestation in walnut allergic patients.
Objective(s):
Primary study objectives:
Investigation of effect of Omeprazole on the threshold dose-distribution curve and the severity of the clinical manifestation of walnut allergic patients.
Secondary study objectives:
Determination of minimal eliciting dose of walnut protein in walnut allergic patients Calculation of the dose of walnut protein leading to an allergic reaction in 5% (ED05) and 10% (ED10) of walnut allergic population Analyse differences in walnut threshold distributions curves and severity related to allergen sensitisation pattern and geographical location.
Outcome(s):
Primary outcome Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole.
Secondary outcome Determination of threshold dose-distribution curve in walnut allergy and calculation of the dose of walnut protein leading to allergic reactions in patients with confirmed food allergy to walnuts.
Study design:
Multicentre, randomised, placebo-controlled; cross-over design.
Selection criteria:
Key inclusion criteria
- positive case history of immediate allergic reaction(s) to walnut
- age ≥ 18 years
- presence of specific IgE to walnut defined as a positive (≥ 3 mm wheal diameter) skin prick test and/or a serum IgE to walnut ≥ 0.35 kU/L ( ImmunoCAP).
Key exclusion criteria
- intake of drugs interfering with Omeprazole or the allergic response under food challenge
- pregnancy, breastfeeding
- acute allergic disease
- any contraindication to adrenaline or to food challenge.
Measurements and procedures:
Skin-prick-testing with different extracts, blood sampling for immunological testing, double-blind placebo controlled food challenge with walnut with/without previous Omeprazole.
Study Product / Intervention:
Omeprazole: Omeprazole Sandoz capsules 40 mg® One treatment run of 5 days, 40 mg (1 capsule) per day
Control Intervention (if applicable):
Placebo capsules containing mannitol Two treatment runs of 5 days, 1 capsule per day
Number of Participants with Rationale:
Two clinical centers will participate in this study, Madrid-Spain (ES) and Zürich-Switzerland (CH). These two centers have been included because the allergens involved in walnut allergy differ, and this will allow to study geographical differences related to the allergen sensitization profile. In Spain patients are sensitized to stable walnut allergens such as lipid transfer proteins (LTP) and storage proteins, whereas in Switzerland patients allergic to walnut are sensitized to labile allergens homologous to Bet v 1.
The final study population for each center will consist of 30 subjects with a challenge confirmed walnut allergy. This sample size will allow to build the probabilistic models to determine threshold dose distribution curves of walnut and calculate the ED05 and ED10. At the same time a population of n=60 will allow to find differences between patients treated with omeprazol and placebo analysed by discrete time survival analysis, given that for a hazard ratio of 2.5, and an anticipated 30% of right censoring, with a confidence level of 95% (α=0.05) and a 90% statistical power (β=0.10) a sample size of 36 subjects is enough.
Due to our experience the investigators will have to include 60 patients at each site with a positive case history of walnut allergy undergoing food challenges to identify 30 patients at each site with a positive food challenge
Statistical Considerations:
The final study population for each center will consist of 30 subjects with a challenge confirmed walnut allergy. This sample size will allow to build the probabilistic models to determine threshold dose distribution curves of walnut and calculate the ED05 and ED10. At the same time a population of n=60 will allow to find differences between patients treated with omeprazol and placebo analysed by discrete time survival analysis, given that for a hazard ratio of 2.5, and an anticipated 30% of right censoring, with a confidence level of 95% (α=0.05) and a 90% statistical power (β=0.10) a sample size of 36 subjects is enough.
GCP Statement:
This study will be conducted according to the standards established by ICH-GCP, The Clinical Trials Directive (2001/20/EC), the Declaration of Helsinki and any applicable local laws. The study will require approval from the Local Ethics Committees and authorization from the National Medicines Agency in each country (AEMPS, Swissmedic) prior to initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Active Drug - Active Meal | Active comparator | Drug: Omeprazol - WalnutOne treatment run of 5 days of Omeprazol 40 mg (1 capsule) per day. In the fifth day patient will receive a walnut challenge set consists of 9 portions served at an interval of 20-30 minutes. |
| Arma B: Placebo Drug - Active Meal | Placebo comparator | Drug: Manitol - WalnutOne treatment run of 5 days of Mannitol. In the fifth day patient will receive a walnut challenge set consists of 9 portions served at an interval of 20-30 minutes. |
| Arm C: Placebo Drug - Placebo Meal | Placebo comparator | Drug: Manitol - Placebo MealOne treatment run of 5 days of Mannitol. In the fifth day patient will receive a placebo challenge set consists of 9 portions served at an interval of 20-30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Positive case history of immediate allergic reaction(s) to walnut
- Presence of specific IgE to walnut assessed by either SPT (≥ 3 mm mean wheal diameter) or serum IgE determination (≥ 0.35 kU/L) by ImmunoCAP (ThermoFisher Scientific, Uppsala, Sweden) in the previous 12 months.
- Informed Consent as documented by signature
Key exclusion criteria (25 listed)
- Known hypersensitivity or allergy to Omeprazole or other PPI
- Known hypersensitivity or allergy to mannitol
- Drugs not allowed during the study due to proved interaction with Omeprazole: Digoxin, Clopidogrel, Methotrexate, Antiretroviral drugs, Diazepam, Cilostazol, Phenytoin, Warfarin (R-Warfarin) and other Vitamin K antagonists, Phenytoin, Tacrolimus, Drugs suppressing or inducing CYP2C19 or CYP3A4 such as Clarithromycin, Voriconazol, Rifampicin and Hypericum
- Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge)
- Women who are pregnant or breast feeding
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 |
|---|---|---|
| Omeprazol - Walnut | Drug | Arm A: Active Drug - Active Meal |
| Manitol - Walnut | Drug | Arma B: Placebo Drug - Active Meal |
| Manitol - Placebo Meal | Drug | Arm C: Placebo Drug - Placebo Meal |
Primary outcome
Dose of walnut protein leading to allergic reactions in 5% (ED05)
Time frame: 1.5-8.5 months
Determination of threshold dose-distribution curve in walnut allergy and calculation of the dose of walnut protein leading to allergic reactions in 5% (ED05) patients with confirmed food allergy to walnuts.
2 secondary outcomes
Dose of walnut protein leading to allergic reactions in 10% (ED10)
Time frame: 1.5-8.5 months
Determination of differences in threshold and severity related to allergen sensitization pattern and geographical location.
Time frame: 1.5-8.5 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 28 Oct 2026.
- 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.
Montserrat Fernández-Rivas, MD, PhD principal investigator
Hospital Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazol - Walnut and Manitol - Walnut in people with Pharmacological Actions, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 25 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 28 Oct 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 Spain. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Dose of walnut protein leading to allergic reactions in 5% (ED05) (time frame: 1.5-8.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.