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

Primary Purpose

Food Allergy

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Omeprazole
Placebo
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Food Allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinico San Carlos
  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Omeprazole

Placebo

Arm Description

patients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge

patients will take Mannitol, in capsules, once a day, during five days before walnut challenge

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 14, 2015
Last Updated
May 10, 2017
Sponsor
University of Zurich
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Nebraska Lincoln, Region Hovedstadens Apotek, University of Manchester, Hospital San Carlos, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02552537
Brief Title
iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
Acronym
iFAAM-PPI
Official Title
Integrated Approaches to Food Allergen and Allergy Risk Management: iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), University of Nebraska Lincoln, Region Hovedstadens Apotek, University of Manchester, Hospital San Carlos, Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omeprazole
Arm Type
Active Comparator
Arm Description
patients will take Omeprazole 40mg, in capsules, once a day, during five days before walnut challenge
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
patients will take Mannitol, in capsules, once a day, during five days before walnut challenge
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Omeprazol Sandoz eco Kps 40
Intervention Description
patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Mannitol
Intervention Description
patients with walnut allergy will be exposed during 5 days before food challenge with Placebo
Primary Outcome Measure Information:
Title
amount of walnuts that induces an allergic reaction assessed in milligram
Description
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
Time Frame
up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clare Mills, Prof, PhD
Organizational Affiliation
University Manchester
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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