Efficacy of an Anti Inflammatory Diet Combined With Physical Therapy on Disease Severity and Inflammatory Markers in Children With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Psoriasis Severity Assessed by the Pediatric Psoriasis Area and Severity Index (P-PASI)
研究概览
简要总结
Purpose and Hypotheses The purpose of this study is to find out if changing the diet and adding exercise can help children with psoriasis. Psoriasis is a skin condition that causes red, scaly patches and is linked to inflammation inside the body. We want to see if a special diet that avoids gluten and foods high in histamine can improve children's skin and reduce inflammation. We will also test if adding a fun physical therapy program with light exercise, stretching, and relaxation provides even more benefits, especially for their overall well-being and quality of life.
Study Details:
Study Duration: 14 weeks in total (this includes a 2-week screening period and the 12-week treatment period).
Treatment Duration: 12 weeks.
Visit Frequency: Participants will come to the clinic for assessments at the start of the study, after 6 weeks, and after 12 weeks. During the 12-week treatment period, participants in the exercise group will attend supervised physical therapy sessions three times a week.
What Will Happen in the Study? Sixty (60) children aged 6 to 17 with mild to moderate psoriasis will be invited to take part. They will be put into one of three groups by chance, like drawing lots. One group will continue with their regular skin care. A second group will follow a special anti-inflammatory diet. This means they will avoid foods with gluten (like wheat bread) and foods high in histamine (like aged cheese or fermented foods) and will eat more fruits, vegetables, and healthy fish. A third group will follow the same diet and also take part in a physical therapy program three times a week. The physical therapy will include light exercise, fun movement activities, and relaxation exercises.
Who Can Participate?
We are looking for children who:
Have been diagnosed with plaque psoriasis for at least 6 months.
Have mild to moderate psoriasis.
Are not taking any new psoriasis medications.
Study Interventions:
Dietary Intervention: A structured anti-inflammatory diet that is gluten-free and low in histamine.
Physical Therapy: A supervised program of low-impact aerobic activities, stretching, and relaxation exercises.
This study is not currently available through an expanded access program.
详细描述
This is a prospective, assessor-blinded, three-arm randomized controlled trial designed to evaluate the efficacy of a gluten-free, low-histamine anti-inflammatory diet, with or without a structured physical therapy program, on disease severity and inflammatory biomarkers in children with psoriasis. The study will be conducted over 12 weeks at the outpatient clinics of Cairo University's Faculty of Physical Therapy and Department of Dermatology.
Study Population:
Sixty (60) children, aged 6 to 17 years, with a confirmed diagnosis of plaque psoriasis (P-PASI ≤ 20) for at least six months.
Study Design:
Participants will be randomly assigned to one of three parallel groups (n=20 per group) using a computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. Outcome assessors (a dermatologist and a laboratory technician) will be blinded to group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessors (the dermatologist performing the P-PASI assessments and the laboratory technician analyzing blood samples) will be blinded to group allocation. Participants will be instructed not to discuss their intervention with the assessors. The treating physical therapist and dietitian cannot be blinded due to the nature of the interventions. The statistician will receive data coded by participant ID only, without group identifiers, for the primary analysis.
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of plaque psoriasis by a board-certified dermatologist for at least six months prior to enrollment.
- •Age between 6 and 17 years (inclusive) at the time of enrollment.
- •Mild to moderate disease severity, defined as a Pediatric Psoriasis Area and Severity Index (P-PASI) score ≤ 20 at the screening visit.
- •Stable psoriasis treatment regimen (topical or systemic) for at least eight weeks prior to the baseline assessment. Participants may continue their usual treatments throughout the study.
- •Ability to comply with the dietary protocol (gluten-free, low-histamine anti-inflammatory diet) and, for Group C, the physical therapy program, as judged by the investigator.
- •Written informed consent from a parent or legal guardian.
- •Written assent from the child (for participants aged 8-17 years). For children aged 6-7 years, verbal assent will be documented.
- •Ability to attend all scheduled study visits at the outpatient clinics of Cairo University.
排除标准
- •Known celiac disease or confirmed wheat allergy (documented by prior diagnostic testing).
- •Current use of anticoagulant medications or systemic corticosteroids.
- •Presence of other chronic inflammatory or autoimmune diseases that could confound the results (e.g., juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus).
- •Severe obesity defined as body mass index (BMI) greater than the 99th percentile for age and sex, which would limit participation in physical activity.
- •Mental, behavioral, or developmental disorders that would prevent the child from cooperating with the dietary or physical therapy interventions or completing the assessments.
- •Participation in another interventional clinical trial within the previous three months prior to enrollment.
- •Any acute illness at the time of recruitment (e.g., febrile illness, acute infection, or acute exacerbation of psoriasis requiring immediate medical intervention).
- •Known intolerance or allergy to multiple foods included in the diet (e.g., fish, nuts, or other common food allergens) that would make it difficult to adhere to the dietary protocol.
- •Receiving any investigational drug or biologic therapy for psoriasis within the previous three months.
- •Concurrent participation in another weight loss or exercise program that would interfere with the study interventions.
研究组 & 干预措施
Standard Care (Control Group)
Participants in this group will continue their usual dermatologic care as prescribed by their treating physician. This includes standard topical treatments (e.g., corticosteroids, vitamin D analogues) or other stable systemic therapies. No dietary modifications or physical therapy interventions will be provided as part of the study protocol. Participants will attend clinic visits for assessments at baseline, 6 weeks, and 12 weeks.
干预措施: Standard Dermatologic Care (Other)
Anti-Inflammatory Diet Only
Participants in this group will receive a 12-week structured anti-inflammatory diet that is gluten-free and low in histamine, designed by a registered pediatric dietitian. The diet eliminates all gluten sources (wheat, barley, rye, and contaminated oats) and restricts high-histamine foods (aged cheeses, fermented dairy products, cured meats, canned fish, spinach, tomatoes, eggplant, avocado, bananas, chocolate, and nuts). Participants are encouraged to consume fresh fruits, vegetables, lean proteins, omega-3-rich fish, olive oil, and gluten-free grains. For overweight or obese children, a mild energy restriction (250-500 kcal/day deficit) is included. Participants continue their usual dermatologic care. Dietary adherence is monitored via three-day food diaries and weekly adherence scales.
干预措施: Anti-Inflammatory Diet (Gluten-Free, Low-Histamine) (Dietary Supplement)
Anti-Inflammatory Diet with Physical Therapy
Participants in this group will receive the same 12-week anti-inflammatory diet (gluten-free, low-histamine) as described for Arm 2. In addition, they will participate in a 12-week structured physical therapy program consisting of 45-minute sessions, three times per week. Each session includes: a 10-minute warm-up (light walking or cycling), a 25-minute main component of low-impact aerobic activities (supervised swimming, adapted dance, or circuit training), and a 10-minute relaxation and breathing component (yoga poses, diaphragmatic breathing). Sessions are led by a pediatric physical therapist. Participants continue their usual dermatologic care.
干预措施: Physical Therapy Program (Other)
结局指标
主要结局
Change in Psoriasis Severity Assessed by the Pediatric Psoriasis Area and Severity Index (P-PASI)
时间窗: Baseline, 6 weeks, and 12 weeks
The P-PASI is a validated instrument that combines the extent of body surface area involvement and the intensity of erythema, thickness, and scaling. Scores range from 0 to 72, with higher scores indicating more severe disease. The P-PASI will be assessed by a board-certified dermatologist who is blinded to group assignment.
次要结局
- Change in High-Sensitivity C-Reactive Protein (hs-CRP) Levels(Baseline, 6 weeks, and 12 weeks)
- Change in Interleukin-6 (IL-6) Levels(Baseline, 6 weeks, and 12 weeks)
- Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels(Baseline, 6 weeks, and 12 weeks)
- Change in Health-Related Quality of Life Assessed by the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales(Baseline, 6 weeks, and 12 weeks)
- Change in Functional Exercise Capacity Assessed by the Six-Minute Walk Test (6MWT)(Baseline and 12 weeks)
- Change in Body Mass Index (BMI) Percentile(Baseline, 6 weeks, and 12 weeks)
- Dietary Adherence Assessed by Three-Day Food Diaries(Baseline, 6 weeks, and 12 weeks)
- Dietary Adherence Assessed by a 10-Point Visual Analog Scale(Weeks 1 through 12)
- Physical Therapy Session Attendance Rate(Weeks 1 through 12)
- Number of Participants with Adverse Events(Weeks 1 through 12)
研究者
Mahmoud Usama Mahmoud Ahmed
Lecturer of Department of Physical Therapy for Paediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.
Cairo University