Quality of Life in Systemic Nickel Allergy Syndrome

Completed

• Conditions: Systemic Nickel Allergy Syndrome; Quality of Life
• Interventions: Biological: Nickel oral hyposensitization treatment

• Registration Number: NCT03731494
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

This study evaluates the effects of Nickel oral hyposensitization treatment (NiOHT) on health-related quality of life (HRQoL) of patients suffered from Systemic Nickel Allergy Syndrome (SNAS).

Detailed Description

Nickel (Ni) is a nutritionally essential metal widely distributed in the environment, and it has been reported to be one of the most common causes of allergic contact dermatitis (ACD), affecting nearly 15-20% of the general population. As known, Ni-hypersensitivity can induce less frequently also respiratory allergy (RA) and in approximately 20% of Ni-ACD patients cause a more complex condition termed Systemic Nickel Allergy Syndrome (SNAS). It is characterized by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Ni-rich foods, especially vegetables. Then, a low-Ni diet, following positive patch tests, represents a effective diagnostic and therapeutic tool in the control of systemic manifestations, determining a significant clinical improvement.

It is known that Nickel oral hyposensitization treatment (NiOHT) is a effective approach for the management of Ni allergy, especially in a subset of patients with SNAS, inducing immunological and clinical tolerance to metal at the doses normally taken with the diet.

Although a large number of clinical trials focused on the health-related quality of life (HRQoL) in allergic disease, the expectations, the needs and the psychosocial characteristics of patients affected by SNAS are limited and no data exist pre- and post-treatment and specifically with NiOHT. Given the high safety profile and beneficial effects of immunotherapy on HRQoL of patients with allergic rhinitis, we hypothesized similar positive results even after oral Ni desensitization.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-03
• Study First Posted: 2018-11-06
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-02
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms),
• positive Ni-patch test,
• clinical improvement at least 70% from baseline after 4 weeks on a low-Ni diet,
• positivity of a double blind placebo-controlled oral Ni challenge (DBPCO),
• written informed consent.

Exclusion Criteria

• 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 tumor,
• concomitant treatment with steroids and/or antihistamines in the previous 4 weeks, pregnancy, lactation,
• smoking, abuse of alcohol, coffee, tea, and cola intake,
• refusal to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nickel oral hyposensitization treatment	Nickel oral hyposensitization treatment	The patients take capsules at different doses in nickel content until reaching the maximum dose of 1.5 mcg per week for a total of 12 months.

Primary Outcome Measures

Name	Time	Method
QoL: Psychological General Well Being Index (PGWBI)	Change from baseline index at 12 months	The PGWBI consists of 22 questions, which deal with six factors (anxiety, depression, vitality, general health,self-control and well-being) constituting a global assessment.The response format is graded 1-6 (i.e. total range 22-132), with the highest value corresponding to optimal well-being.
QoL: Short-Form 36-Item Health Survey (SF-36v2)	Change from baseline index at 12 months	Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively.

Secondary Outcome Measures

Name	Time	Method
Psychological state: Minnesota Multiphasic Personality Inventory (MMPI-2)	Baseline.	The MMPI-2 questionnaire containing 567 items with 2 choices of answer ("true" or "false") in order to assess the main structural features of personality and emotional disorders.

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Roma, Italy