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

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.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Drug: Omeprazole; Drug: Placebo

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: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Clinico San Carlos
• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Mannitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 18 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); University of Manchester; Hospital San Carlos, Madrid; University of Nebraska Lincoln; Region Hovedstadens Apotek
• Investigators: Study Chair: Clare Mills, Prof, PhD, University Manchester

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 14, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Anti-Ulcer Agents; Proton Pump Inhibitors; Mannitol; Omeprazole
• Other Study ID Numbers: KEK 2015-0380