The Role of Food Sensitivity in Psoriasis: a 12-week Prospective Correlational Study of the Impact of an Individualized Elimination Diet on Disease Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- IgE Antibodies
研究概览
简要总结
Psoriasis is a common chronic skin disorder that affects over 4 million people. There is no cure for psoriasis and treatment is directed at controlling patients' symptoms. The purpose of this study is to determine whether psoriasis patients are more likely to have food sensitivities than those patients without psoriasis. We will also determine if eliminating certain foods from the diet results in a change in psoriasis symptoms.
详细描述
Purpose: To determine the role of food sensitivity in psoriasis and assess the clinical response of an individualized elimination diet on psoriasis.
Design: Up to 50 volunteers with psoriasis and 20 age- and sex-matched controls will be recruited for a 12-week prospective correlational study.
Methods: Venous blood samples for the detection of antibodies against food antigens will be collected and individualized elimination diets will be designed based on the most reactive food antigens.
Assessments: Clinical assessments of objective and subjective parameters will be measured using Psoriasis Area and Severity Index (PASI), Static Physicians Global Assessment (sPGA), Dermatology Life Quality Index (DLQI), and Itch Numeric Rating Scale (Itch NRS).
Objectives: The primary objectives are to determine whether psoriasis patients are more likely to have food sensitivities and assess the clinical response of a 12-week elimination diet on psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
IgE Antibodies
时间窗: 12 weeks
IgE Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Anti-Tissue Transglutaminase (tTG) IgA
时间窗: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgA Change from Baseline in Psoriasis Patients vs. Controls
IgG4 Antibodies
时间窗: 12 weeks
IgG4 Antibodies against Eliminated Food Antigens in Psoriasis Patients vs. Controls
Anti-Tissue Transglutaminase (tTG) IgG
时间窗: 12 weeks
Anti-Tissue Transglutaminase (tTG) IgG Change from Baseline in Psoriasis Patients vs. Controls
Anti-Deamidated Gliadin Peptide (DGP) IgG
时间窗: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgG Change from Baseline in Psoriasis Patients vs. Controls
Anti-Deamidated Gliadin Peptide (DGP) IgA
时间窗: 12 weeks
Anti-Deamidated Gliadin Peptide (DGP) IgA Change from Baseline in Psoriasis Patients vs. Controls
次要结局
- Anti-Deamidated Gliadin Peptide (DGP) IgG in Subset(12 weeks)
- Anti-Tissue Transglutaminase (tTG) IgG in Subset(12 weeks)
- IgG4 Antibodies in Subset(12 weeks)
- Anti-Tissue Transglutaminase (tTG) IgA in Subset(12 weeks)
- IgE Antibodies in Subset(12 weeks)
- Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset(12 weeks)
研究者
Yolanda Rosi Helfrich
Director Program for Clinical Research In Dermatology
University of Michigan