Psoriasis
Conditions
Keywords
Anti inflammatory diet, gluten free, low histamine, physical therapy, psoriasis, children, inflammation, quality of life
Brief summary
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.
Detailed description
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. Interventions: Group A (Standard Care): Participants will continue their usual dermatologic care as prescribed by their physician, without any dietary or physical therapy intervention. Group B (Diet Only): Participants will receive a 12-week anti-inflammatory diet that is gluten-free and low in histamine, designed by a registered pediatric dietitian. The diet eliminates all sources of gluten and foods high in histamine. For overweight or obese participants, a mild energy restriction will be included. Dietary adherence will be monitored via three-day food diaries. Group C (Diet + Physical Therapy): Participants will receive the same dietary intervention as Group B, in addition to a 12-week physical therapy program. This program consists of 45-minute sessions, three times per week, comprising a warm-up, low-impact aerobic activities, and relaxation/breathing exercises. Sessions will be led by a pediatric physical therapist. Study Schedule: Assessments will be conducted at baseline (Week 0), mid-intervention (Week 6), and post-intervention (Week 12). The total duration of study participation for each participant is 14 weeks, including a 2-week screening period and a 12-week treatment period. Statistical Analysis: Data will be analyzed using a mixed repeated-measures ANOVA to test for group × time interactions. Intention-to-treat analysis will be performed. The significance level will be set at p \< 0.05. Sample size calculation (n=20 per group) is based on an expected moderate effect size for the difference in P-PASI change between groups, with 80% power and α = 0.05. Ethical Considerations: The study protocol has been approved by the Faculty of Physical Therapy Research Ethics Committee at Cairo University. All participants and their parents or legal guardians will provide written informed consent and assent (for children 8-17 years) before enrollment. The study will be conducted in accordance with the Declaration of Helsinki and applicable local regulations.
Interventions
DIETARY_SUPPLEMENTAnti-Inflammatory Diet (Gluten-Free, Low-Histamine)
A structured 12-week dietary intervention that eliminates all sources of gluten (wheat, barley, rye, spelt, and contaminated oats) and restricts foods high in histamine (aged cheeses, fermented dairy products, cured meats, canned fish, spinach, tomatoes, eggplant, avocado, bananas, chocolate, nuts). The diet emphasizes fresh, unprocessed foods with anti-inflammatory properties: leafy green vegetables, berries, olive oil, fresh fatty fish (salmon, mackerel, herring), lean poultry, legumes, gluten-free grains (rice, quinoa, millet, buckwheat), and herbs such as turmeric and ginger. For overweight or obese participants, a mild energy restriction (250-500 kcal/day deficit) is applied. The diet is designed by a registered pediatric dietitian to ensure nutritional adequacy.
OTHERPhysical Therapy Program
A 12-week structured physical therapy program delivered in 45-minute sessions, three times per week. Each session consists of three components: (1) Warm-up: light walking or stationary cycling for 10 minutes; (2) Main exercise: low-impact aerobic activities such as supervised swimming, adapted dance routines, or playground-based circuit training (stepping, gentle jumping, stretching) for 25 minutes; (3) Relaxation: age-appropriate yoga poses (child's pose, cat-cow, butterfly) and diaphragmatic breathing exercises for 10 minutes. Sessions are conducted in a hospital-based pediatric rehabilitation gym and led by a pediatric physical therapist with at least five years of experience. The program is designed to be enjoyable and non-punitive for children.
OTHERStandard Dermatologic Care
Participants will continue their usual psoriasis treatment as prescribed by their dermatologist. This may include topical corticosteroids, vitamin D analogues, or other stable systemic therapies. No study-specific changes will be made to the participants' regular medication regimens, and all treatments will remain unchanged throughout the 12-week study period unless clinically indicated.
Sponsors
Mahmoud Usama Mahmoud Ahmed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psoriasis Severity Assessed by the Pediatric Psoriasis Area and Severity Index (P-PASI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) Levels | Baseline, 6 weeks, and 12 weeks | Hs-CRP will be measured from fasting venous blood samples collected between 8:00 and 10:00 AM. Assays will be performed using immunoturbidimetry. |
| Change in Interleukin-6 (IL-6) Levels | Baseline, 6 weeks, and 12 weeks | IL-6 will be quantified from fasting venous blood samples using enzyme-linked immunosorbent assay (ELISA) kits (R\&D Systems, Minneapolis, MN, USA). All assays will be performed in duplicate by a technician blinded to group allocation. |
| Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels | Baseline, 6 weeks, and 12 weeks | TNF-α will be quantified from fasting venous blood samples using enzyme-linked immunosorbent assay (ELISA) kits (R\&D Systems, Minneapolis, MN, USA). All assays will be performed in duplicate by a technician blinded to group allocation. |
| 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 | The PedsQL 4.0 Generic Core Scales will be administered to children (self-report for ages 8-17) and parents (proxy-report for ages 6-17). The total score ranges from 0 to 100, with higher scores indicating better quality of life. |
| Change in Functional Exercise Capacity Assessed by the Six-Minute Walk Test (6MWT) | Baseline and 12 weeks | The 6MWT will be performed only in Group C (Diet + Physical Therapy). Children will be instructed to walk as far as possible along a 30-meter corridor for six minutes, with standardized encouragement. The distance walked in meters will be recorded. |
| Change in Body Mass Index (BMI) Percentile | Baseline, 6 weeks, and 12 weeks | Height and weight will be measured at each assessment visit. BMI percentile will be calculated using CDC growth charts for age and sex. |
| Dietary Adherence Assessed by Three-Day Food Diaries | Baseline, 6 weeks, and 12 weeks | Parents will complete three-day food diaries (two weekdays, one weekend day) at each assessment time point. Adherence to the gluten-free and low-histamine dietary protocol will be evaluated by the study dietitian. |
| Dietary Adherence Assessed by a 10-Point Visual Analog Scale | Weeks 1 through 12 | Parents will complete a weekly 10-point visual analog scale (0 = no adherence, 10 = perfect adherence) to self-report their child's adherence to the dietary protocol over the preceding week. |
| Physical Therapy Session Attendance Rate | Weeks 1 through 12 | Attendance at each scheduled physical therapy session will be recorded for participants in Group C (Diet + Physical Therapy). The attendance rate will be calculated as the percentage of completed sessions out of 36 possible sessions. |
| Number of Participants with Adverse Events | Weeks 1 through 12 | Any episode of skin worsening, gastrointestinal discomfort, joint pain, muscle soreness, unusual fatigue, or other adverse events will be recorded throughout the study. All adverse events will be categorized as mild, moderate, or severe. |
Countries
Egypt
Contacts
CONTACTMahmoud Usama, Lecturer
Outcome results
None listed