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

Food Allergy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552537
• Other study ID #: KEK 2015-0380
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2015
• Last updated: May 10, 2017
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Omeprazole
patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole
• Placebo
patients with walnut allergy will be exposed during 5 days before food challenge with Placebo

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid
Switzerland	University Hospital Zurich	Zurich

Sponsors (6)

Lead Sponsor	Collaborator
University of Zurich	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Hospital San Carlos, Madrid, Region Hoverstaden, University of Manchester, University of Nebraska Lincoln

Countries where clinical trial is conducted

Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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