Food AllergyPhase 4iFAAM-PPINCT02552537
iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
A Phase 4 study testing Omeprazole in people with Food Allergy, run by University of Zurich at 2 sites in 2 countries.
Trial summary
In patients with a walnut allergy double blind placebo controlled food challenge with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on threshold level and on clinical manifestation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Allergy
- What is being tested?
- Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2015to Mar 2017
- 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
- signed informed consent, history of walnut allergy,minimum age 18 years
Who cannot join
- • Known hypersensitivity or allergy to Omeprazole, other proton pump inhibitors, mannitol, ingredients of placebo meal
- 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, Clarithromycin, voriconazole, 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 hydroxyzine (10 days)
- ketotifen (2 weeks)
Show all 21Show fewer
- betablocker (1 day)
- angiotensin converting enzyme (ACE) inhibitors (2 days)
- omalizumab (2 months)
- 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
- Please note that 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, forced expiratory volume <70% predicted value
- Acute allergic disease
- Chronic urticaria
- Mastocytosis
- Other clinically significant concomitant disease states (major organic or infectious diseases, e.g., renal failure, hepatic dysfunction, cardiovascular disease, acute febrile infection),
- 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Integrated Approaches to Food Allergen and Allergy Risk Management: iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
In patients with a walnut allergy double blind placebo controlled food challenge with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on threshold level and on clinical manifestation.
Read the detailed description
- detailed case history, blood sampling and prick testing with different foods will performed.
- double blind food provocation with with three meals containing either placebo or walnut in walnut allergic patients will be performed.
- the provocation will be combined with the intake of drug (omeprazole) or placebo (mannitol) blinded in capsules.
- Conditions
- Food Allergy
- Being tested
- Omeprazole, Placebo
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Omeprazol Sandoz eco Kps 40
patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole
PlaceboDrug
Also called Mannitol
patients with walnut allergy will be exposed during 5 days before food challenge with Placebo
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole | Active comparator | patients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge Receives: Drug: Omeprazole |
| Placebo | Sham comparator | patients will take Mannitol, in capsules, once a day, during five days before walnut challenge Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of walnuts that induces an allergic reaction assessed in milligram
The amount of walnut which induces an allergic reaction in walnut allergic patients will be assessed in milligram by titrated challenges under concommitant intake of therapeutic doses of omeprazole versus placebo
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Nebraska Lincoln, Region Hovedstadens Apotek, University of Manchester, Hospital San Carlos, Madrid
- Responsible party
- Sponsor
- Investigators
- Clare Mills, Prof, PhD, Study chair, University Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552537
- Sponsor's protocol ID
- KEK 2015-0380
- Acronym
- iFAAM-PPI
- Status last verified
- May 2017
- First submitted
- 14 Sep 2015
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Approaches to Food Allergen and Allergy Risk Management: iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
- ClinicalTrials.gov ID
- NCT02552537
- Acronym / sponsor ID
- iFAAM-PPI / KEK 2015-0380
- Conditions
- Food Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Nebraska Lincoln, Region Hovedstadens Apotek, University of Manchester, Hospital San Carlos, Madrid
- Study start
- Sep 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with a walnut allergy double blind placebo controlled food challenge with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on threshold level and on clinical manifestation.
Detailed description
- detailed case history, blood sampling and prick testing with different foods will performed.
- double blind food provocation with with three meals containing either placebo or walnut in walnut allergic patients will be performed.
- the provocation will be combined with the intake of drug (omeprazole) or placebo (mannitol) blinded in capsules.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Active comparator | Drug: Omeprazolepatients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge |
| Placebo | Sham comparator | Drug: Placebopatients will take Mannitol, in capsules, once a day, during five days before walnut challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- signed informed consent, history of walnut allergy,minimum age 18 years
Key exclusion criteria (21 listed)
- • Known hypersensitivity or allergy to Omeprazole, other proton pump inhibitors, mannitol, ingredients of placebo meal
- corticosteroids systemically (2 weeks)
- antihistamines (3 days) except hydroxyzine (10 days)
- ketotifen (2 weeks)
- betablocker (1 day)
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 |
|---|---|---|
| OmeprazoleAlso: Omeprazol Sandoz eco Kps 40patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole | Drug | Omeprazole |
| PlaceboAlso: Mannitolpatients with walnut allergy will be exposed during 5 days before food challenge with Placebo | Drug | Placebo |
Primary outcome
amount of walnuts that induces an allergic reaction assessed in milligram
Time frame: up to 18 months
The amount of walnut which induces an allergic reaction in walnut allergic patients will be assessed in milligram by titrated challenges under concommitant intake of therapeutic doses of omeprazole versus placebo
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 11 May 2017.
Related trials for Food Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Not yet recruiting
Rapid Escalation Oral Immunotherapy to Achieve Remission in Children With Cashew Allergy
Food Allergy in Children
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
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.
Clare Mills, Prof, PhD study chair
University Manchester
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omeprazole in people with Food Allergy, run by University of Zurich at 2 sites in 2 countries.
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 1 inclusion and 21 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, Switzerland. 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?
amount of walnuts that induces an allergic reaction assessed in milligram (time frame: up to 18 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 11 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.