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临床试验/NCT03731494
NCT03731494已完成不适用

Quality of Life Assessment Before and After Hyposensitization Treatment in Systemic Nickel Allergy Syndrome

Catholic University of the Sacred Heart1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
QoL: Psychological General Well Being Index (PGWBI)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

QoL: Psychological General Well Being Index (PGWBI)

时间窗: 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)

时间窗: 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.

次要结局

  • Psychological state: Minnesota Multiphasic Personality Inventory (MMPI-2)(Baseline.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleonora Nucera

Prof.

Catholic University of the Sacred Heart

研究点 (1)

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