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
- 1
- 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
- •Male or female subjects, 12 years of age or older.
- •Good general health.
- •Willingness and ability to follow the protocol.
- •Signed Informed Consent Form, written and witnessed.
- •Psoriatic group only: Chronic plaque psoriasis (patients must have diagnosis for at least 6 months) or guttate psoriasis involving 2 % or greater total body surface area or 2 plaques, each measuring > 8 cm
- •Psoriatic group only: Psoriasis is untreated (as defined in
排除标准
- •or subject has been on a stable topical or systemic treatment with no dose alteration or regimen alteration for >12 months.
- •Exclusion criteria:
- •History of drug-induced psoriasis or pustular psoriasis.
- •Moderate or severe psoriasis warranting systemic immunosuppression or inpatient admission.
- •Pregnant, lactating, history of diabetes mellitus, thyroid disease or inflammatory bowel disease.
- •Psoriatic group only: Use of biologic treatment for psoriasis within 3 months of baseline, use of systemic immunosuppressive treatment for psoriasis within 4 weeks of baseline, or use of topical treatment for psoriasis within 2 weeks.
研究组 & 干预措施
Psoriasis
Psoriasis patients will be placed on an individualized 12-week elimination diet
干预措施: 12-week elimination diet (Other)
Healthy Control
Healthy Control patients will receive no intervention
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
- IgE Antibodies in Subset(12 weeks)
- Anti-Deamidated Gliadin Peptide (DGP) IgA in Subset(12 weeks)
- 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)
研究者
Yolanda Rosi Helfrich
Director Program for Clinical Research In Dermatology
University of Michigan