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

NCT ID: NCT02552537

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-03-31

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.

Conditions

Food Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Omeprazole

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

Group Type: ACTIVE_COMPARATOR

Omeprazole

Intervention Type: DRUG

patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole

Placebo

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

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

patients with walnut allergy will be exposed during 5 days before food challenge with Placebo

Interventions

Omeprazole

patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole

Intervention Type: DRUG

Placebo

patients with walnut allergy will be exposed during 5 days before food challenge with Placebo

Intervention Type: DRUG

Other Intervention Names

Omeprazol Sandoz eco Kps 40; Mannitol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

University of Nebraska Lincoln

OTHER

Sponsor Role: collaborator

Region Hovedstadens Apotek

OTHER_GOV

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clare Mills, Prof, PhD

Role: STUDY_CHAIR

University Manchester

Locations

Hospital Clinico San Carlos

Madrid, , Spain

University Hospital Zurich

Zurich, , Switzerland

Countries

Spain; Switzerland

Other Identifiers

KEK 2015-0380

Identifier Type: -

Identifier Source: org_study_id