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iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions (iFAAM-PPI)

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ClinicalTrials.gov Identifier: NCT02552537
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : May 11, 2017
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Nebraska Lincoln
Region Hoverstaden
University of Manchester
Hospital San Carlos, Madrid
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
Food Allergy Drug: Omeprazole Drug: Placebo Phase 4

Detailed Description:
  1. detailed case history, blood sampling and prick testing with different foods will performed.
  2. double blind food provocation with with three meals containing either placebo or walnut in walnut allergic patients will be performed.
  3. the provocation will be combined with the intake of drug (omeprazole) or placebo (mannitol) blinded in capsules.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Integrated Approaches to Food Allergen and Allergy Risk Management: iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
Study Start Date : September 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Omeprazole
patients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge
Drug: Omeprazole
patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole
Other Name: Omeprazol Sandoz eco Kps 40

Sham Comparator: Placebo
patients will take Mannitol, in capsules, once a day, during five days before walnut challenge
Drug: Placebo
patients with walnut allergy will be exposed during 5 days before food challenge with Placebo
Other Name: Mannitol




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed informed consent, history of walnut allergy,minimum age 18 years

Exclusion Criteria:

  • • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552537


Locations
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Spain
Hospital Clinico San Carlos
Madrid, Spain
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Nebraska Lincoln
Region Hoverstaden
University of Manchester
Hospital San Carlos, Madrid
Investigators
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Study Chair: Clare Mills, Prof, PhD University Manchester

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02552537     History of Changes
Other Study ID Numbers: KEK 2015-0380
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Mannitol
Omeprazole
Antacids
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs