💬In plain words
What the trial is, and whether it could suit you
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 per
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria
1. Confirmed diagnosis of plaque psoriasis by a board-certified dermatologist for at least six months prior to enrollment.
2. Age between 6 and 17 years (inclusive) at the time of enrollment.
3. Mild to moderate disease severity, defined as a Pediatric Psoriasis Area and Severity Index (P-PASI) score ≤ 20 at the screening visit.
4. 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.
5. 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.
6. Written informed consent from a parent or legal guardian.
7. Written assent from the child (for participants aged 8-17 years). For children aged 6-7 years, verbal assent will be documented.
8. Ability to attend all scheduled study visits at the outpatient clinics of Cairo University.
Exclusion Criteria
1. Known celiac disease or confirmed wheat allergy (documented by prior diagnostic testing).
2. Current use of anticoagulant medications or systemic corticosteroids.
3. Presence of other chronic inflammatory or autoimmune diseases that could confound the results (e.g., juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus).
4. Severe obesity defined as body mass index (BMI) greater than the 99th percentile for age and sex, which would limit participation in physical activity.
5. Mental, behavioral, or developmental disorders that would prevent the child from cooperating with the dietary or physical therapy interventions or completing the assessments.
6. Participation in another interventional clinical trial within the previous three months prior to enrollment.
7. Any acute illness at the time of recruitment (e.g., febrile illness, acute infection, or acute exacerbation of psoriasis requiring immediate medical intervention).
8. 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.
9. Receiving any investigational drug or biologic therapy for psoriasis within the previous three months.
10. Concurrent participation in another weight loss or exercise program that would interfere with the study interventions.
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