An interventional study of Anti-Inflammatory Diet (Gluten-Free, Low-Histamine) and Physical Therapy Program in Psoriasis, sponsored by Mahmoud Usama Mahmoud Ahmed. Completed at 1 site in Egypt. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Mahmoud Usama Mahmoud Ahmed · Not applicable, Interventional, and Treatment
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.
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.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →This is the only study on the registry with Mahmoud Usama Mahmoud Ahmed as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Standard Dermatologic Care
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.
Dietary Supplement: Anti-Inflammatory Diet (Gluten-Free, Low-Histamine)
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.
Other: Physical Therapy Program
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.
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.
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.
Change in Psoriasis Severity Assessed by the Pediatric Psoriasis Area and Severity Index (P-PASI)
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.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in High-Sensitivity C-Reactive Protein (hs-CRP) Levels
Hs-CRP will be measured from fasting venous blood samples collected between 8:00 and 10:00 AM. Assays will be performed using immunoturbidimetry.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Interleukin-6 (IL-6) Levels
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.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels
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.
Time frame: 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
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.
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Functional Exercise Capacity Assessed by the Six-Minute Walk Test (6MWT)
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.
Time frame: Baseline and 12 weeks
Change in Body Mass Index (BMI) Percentile
Height and weight will be measured at each assessment visit. BMI percentile will be calculated using CDC growth charts for age and sex.
Time frame: Baseline, 6 weeks, and 12 weeks
Dietary Adherence Assessed by Three-Day Food Diaries
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.
Time frame: Baseline, 6 weeks, and 12 weeks
Dietary Adherence Assessed by a 10-Point Visual Analog Scale
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.
Time frame: Weeks 1 through 12
Physical Therapy Session Attendance Rate
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.
Time frame: Weeks 1 through 12
Number of Participants with Adverse Events
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.
Time frame: Weeks 1 through 12
Plan to share: No — I do not plan to share individual participant data (IPD) with other researchers for the following reasons: Participant Confidentiality: The study involves children with psoriasis, a condition that can carry social stigma. Even with de-identification, there is a risk that detailed clinical and biomarker data could potentially be re-identified, particularly given the relatively small sample size (n=60) and the specific inclusion/exclusion criteria. Informed Consent Limitations: The consent and assent forms signed by participants and their parents did not include provisions for sharing IPD with external researchers beyond the direct study team. Ethical and regulatory requirements mandate that participants be informed about how their data will be used, and broad sharing was not part of the original consent. Institutional Policy: Cairo University's Faculty of Physical Therapy Research Ethics Committee requires that data remain within the institution unless explicit permission is granted
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