Status:
COMPLETED
Telemedicine for SNAS Patients in COVID-19 Pandemic
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Systemic Nickel Allergic Syndrome
Eligibility:
All Genders
18-65 years
Brief Summary
Restrictions due to Covid-19 pandemic have brought negative social and psychological consequences on people and limited patients' access to hospital care. In this context, "telemedicine" and, specifi...
Detailed Description
There are no previous studies focused on the tele-nutrition for the evaluation of dietary-nutritional status of patients suffered from Systemic Nickel Allergic Syndrome (SNAS). The aims of this study...
Eligibility Criteria
Inclusion
- history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms);
- positive Ni-patch test;
- clinical improvement of at least 70% from baseline after 4 weeks of low-Ni diet;
- positivity of a double-blind placebo-controlled oral Ni challenge (DBPCO).
Exclusion
- age \< 18 years and \>65 years;
- other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth;
- diabetes mellitus;
- hepatic, renal or cardiac dysfunction;
- thyroid disease or tumour;
- concomitant treatment with steroids and/or antihistamines in the previous 4 weeks;
- pregnancy and lactation;
- smoking, abuse of alcohol, coffee, tea, and cola intake;
- inability to give written informed consent.
Key Trial Info
Start Date :
October 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04894331
Start Date
October 8 2020
End Date
November 30 2020
Last Update
May 20 2021
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy, 00168