Status:
COMPLETED
Systemic Nickel Allergy Syndrome: Intervention Study for the Assessment of the Dietary Indications
Lead Sponsor:
University of Pavia
Collaborating Sponsors:
Istituti Clinici Scientifici Maugeri SpA
Conditions:
Nickel Sensitivity
Allergy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Background: Nickel is a silvery metal widely used in nature and contained in many foods. Exposure to nickel is responsible for two different types of adverse reactions: Allergic Contact Dermatitis (DA...
Detailed Description
The primary objective of this intervention study is the evaluation of the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms a...
Eligibility Criteria
Inclusion
- patients on first access aged 18 or over;
- nickel phosphate sensitized patients (patch test: ++ or +++);
- monosensitized or polisensitized patients;
- patients with the presence of allergic gastrointestinal symptoms;
- patients negative to diagnostic tests for other allergies;
- signature of informed consent.
Exclusion
- patients positive for diagnostic tests for other allergies;
- polysensitized patients with additives and preservatives, to exclude any confounding effects;
- patients who have previously received dietary indications for allergy management;
- patients who have been diagnosed with IBD (Irritable Bowel Disease) such as Ulcerative Rectocolitis, Chron's disease, IBS;
- patients in whom a Eating and Nutrition Disorder (DAN) has been diagnosed;
- patients with malignancies.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04432896
Start Date
December 1 2018
End Date
December 1 2020
Last Update
June 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, Italy, 27100