Status:
COMPLETED
Hydroponic Cultivation in Systemic Nickel Allergy Syndrome
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Food Allergy
Food Hypersensitivity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Oral intake of nickel (Ni) is capable of causing the onset of systemic disorders in patients with Systemic Allergy to Nickel Syndrome (SNAS), an emerging allergic condition. Given its ubiquitous age, ...
Eligibility Criteria
Inclusion
- Patients with documented diagnosis of SNAS: a) history of SNAS (coexistence of typical skin symptoms and gastrointestinal symptoms); b) positive nickel sulphate patch test; c) clinical improvement of at least 70% after 4-6 weeks of low-nickel diet; d) positivity of the oral challenge test with nickel sulphate.
- Age between 18 and 65 years.
- Written informed consent to participate in the study.
- Patients who are able to participate in all study procedures and to accept and comply with all study needs throughout the study, including the availability of suitable transportation and the time required to undergo all procedures. planned visits.
Exclusion
- Women who are pregnant or breastfeeding.
- Patients diagnosed with organic diseases capable of affecting gastrointestinal symptoms (eg celiac disease, poorly controlled diabetes, scleroderma, chronic inflammatory bowel diseases). Lactose intolerance is not an exclusion criterion if the diagnosis has been made for more than 6 months and if the patient does not report adequate symptom relief after at least 6 months of a lactose-free diet.
- Patients who have been taking systemic probiotics, antibiotics or systemic corticosteroids within the past 30 days.
- Patients who have been taking antidepressant or anxiolytic drugs for less than a month. On the other hand, patients can be enrolled who have been taking the aforementioned drugs at a stable dosage for at least one month.
- Patients who abuse coffee, tea, coca cola and with a smoking habit.
- Patients with pacemakers because they cannot be subjected to bioimpedance analysis for the assessment of body composition.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05232890
Start Date
February 26 2021
End Date
March 31 2022
Last Update
April 5 2022
Active Locations (1)
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1
UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy, 00168