PPI in walnut allergy

The impact of proton-pump inhibitors (antacids) on threshold dose distributions - iFAAM-PPI walnut

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001863-38-ES

Enrollment

Registered

2015-07-31

Start date

2015-09-24

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

walnut allergic patients MedDRA version: 18.0 Level: PT Classification code 10016946 Term: Food allergy System Organ Class: 10021428 - Immune system disorders

Interventions

Trade Name: Omeprazol Sandoz 40 mg cápsulas duras gastrorresistentes Product Name: omeprazol Product Code: omeprazol Pharmaceutical Form: Capsule, hard INN or Proposed INN: ESOMEPRAZOLE CAS Number: 21

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - positive case history of allergic reaction(s) to walnut - age ? 18 years - cutaneous reaction positive to walnut Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: - intake of drugs interfering with Omeprazole or the allergic response under food challenge - pregnancy, breastfeeding - acute allergic disease - epinefrine contraindication

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigation of effect of Omeprazole on the threshold dose-distribution curve and the severity of the clinical manifestation of walnut allergic patients;Secondary Objective: Determination of minimal eliciting dose of walnut protein in walnut allergic patients Calculation of the dose of walnut protein leading to an allergic reaction in 5% (ED05) and 10% (ED10) of walnut allergic population Analyse differences in walnut threshold distributions curves and severity related to allergen sensitisation pattern and geographical location;Primary end point(s): Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole;Timepoint(s) of evaluation of this end point: 5th treatment day	—

Measure

Time frame

Main Objective: Investigation of effect of Omeprazole on the threshold dose-distribution curve and the severity of the clinical manifestation of walnut allergic patients;Secondary Objective: Determination of minimal eliciting dose of walnut protein in walnut allergic patients Calculation of the dose of walnut protein leading to an allergic reaction in 5% (ED05) and 10% (ED10) of walnut allergic population Analyse differences in walnut threshold distributions curves and severity related to allergen sensitisation pattern and geographical location;Primary end point(s): Change in the threshold dose of walnut that induces an allergic reaction after the intake of therapeutic doses of omeprazole Change in the severity of walnut allergy after the intake of therapeutic doses of omeprazole;Timepoint(s) of evaluation of this end point: 5th treatment day

—

Secondary

Measure	Time frame
Secondary end point(s): Determination of threshold dose-distribution curve in walnut allergy and calculation of the dose of walnut protein leading to allergic reactions in patients with confirmed food allergy to walnuts;Timepoint(s) of evaluation of this end point: 5th treatment day	—

Countries

Spain

Contacts

Public ContactUICEC

Fundación para la investigación biomedica Hospital Clinico San Carlos

fibucicec.hcsc@salud.madrid.org+349133030007360

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026