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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

Tracking Information
First Submitted Date  ICMJE September 14, 2015
First Posted Date  ICMJE September 17, 2015
Last Update Posted Date May 11, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02552537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
Official Title  ICMJE Integrated Approaches to Food Allergen and Allergy Risk Management: iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Food Allergy
Intervention  ICMJE
  • Drug: Omeprazole
    patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole
    Other Name: Omeprazol Sandoz eco Kps 40
  • Drug: Placebo
    patients with walnut allergy will be exposed during 5 days before food challenge with Placebo
    Other Name: Mannitol
Study Arms  ICMJE
  • Active Comparator: Omeprazole
    patients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge
    Intervention: Drug: Omeprazole
  • Sham Comparator: Placebo
    patients will take Mannitol, in capsules, once a day, during five days before walnut challenge
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2017)
44
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2015)
60
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02552537
Other Study ID Numbers  ICMJE KEK 2015-0380
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • University of Nebraska Lincoln
  • Region Hoverstaden
  • University of Manchester
  • Hospital San Carlos, Madrid
Investigators  ICMJE
Study Chair: Clare Mills, Prof, PhD University Manchester
PRS Account University of Zurich
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP