PsoriasisNCT07736651
Anti Inflammatory Diet With Physical Therapy on Psoriasis
A study testing Anti-Inflammatory Diet (Gluten-Free, Low-Histamine), Physical Therapy Program and Standard Dermatologic Care in people with Psoriasis, run by Mahmoud Usama Mahmoud Ahmed at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Anti-Inflammatory Diet (Gluten-Free, Low-Histamine), Physical Therapy Program and Standard Dermatologic Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jul 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Anti Inflammatory Diet Combined With Physical Therapy on Disease Severity and Inflammatory Markers in Children With Psoriasis
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:
Read more
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Anti-Inflammatory Diet (Gluten-Free, Low-Histamine), Physical Therapy Program, Standard Dermatologic Care
- Keywords
- Anti inflammatory diet, gluten free, low histamine, physical therapy, psoriasis, children, inflammation, quality of life
- Medical subject headings
- Psoriasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Inflammatory Diet (Gluten-Free, Low-Histamine)Dietary supplement
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.
Physical Therapy ProgramOther
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.
Standard Dermatologic CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care (Control Group) | Other | 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. Receives: Other: Standard Dermatologic Care |
| Anti-Inflammatory Diet Only | Experimental | 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. Receives: Dietary Supplement: Anti-Inflammatory Diet (Gluten-Free, Low-Histamine) |
| Anti-Inflammatory Diet with Physical Therapy | Experimental | 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. Receives: Other: Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, and 12 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1 through 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start27 Jul 2026
- Primary completion15 Sep 2026
- Study completion1 Nov 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Usama Mahmoud Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Usama Mahmoud Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736651
- Sponsor's protocol ID
- P.T.REC/012/006534
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Updated S2k guideline recommendations for children and adolescents with psoriasis. DERMATOLOGIE PRAXIS. 2022;32(5):39-42. Published October 25, 2022.
van Geel MJ, Otero ME, de Jong EM, van de Kerkhof PC, Seyger MM. Validation of the Simplified Psoriasis Index in Dutch children and adolescents with plaque psoriasis. Br J Dermatol. 2017 Mar;176(3):771-776. doi: 10.1111/bjd.15120. Epub 2016 Dec 8.
PubMed 27718521Farouk S, Aoun R, Muwafak B, Al-Darraji H, Al-Dujaili A. Lifestyle and Nutrition in Psoriasis: Key Factors in Pathogenesis and Disease Modulation. In: Psoriasis - Recent Advances in Diagnosis and Treatment. IntechOpen; 2025. doi: 10.5772/intechopen.1011490.
Perez-Bootello J, Berna-Rico E, Abbad-Jaime de Aragon C, Cova-Martin R, Goni L, Ballester-Martinez A, Jaen-Olasolo P, Mehta N, Gelfand JM, Martinez-Gonzalez MA, Gonzalez-Cantero A. Impact of the Mediterranean Diet on Patients With Psoriasis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 29;14:e64277. doi: 10.2196/64277.
PubMed 39879606De Simoni E, Rizzetto G, Molinelli E, Capodaglio I, Offidani A, Simonetti O. The Role of Diet in Children with Psoriasis: Emerging Evidence and Current Issues. Nutrients. 2023 Mar 31;15(7):1705. doi: 10.3390/nu15071705.
PubMed 37049545
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Anti Inflammatory Diet Combined With Physical Therapy on Disease Severity and Inflammatory Markers in Children With Psoriasis
- ClinicalTrials.gov ID
- NCT07736651
- Acronym / sponsor ID
- P.T.REC/012/006534
- Conditions
- Psoriasis
- Keywords
- Anti inflammatory diet, gluten free, low histamine, physical therapy, psoriasis, children, inflammation, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahmoud Usama Mahmoud AhmedUniversity, hospital or other
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 1 Nov 2026 (actual)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care (Control Group) | Other | Other: Standard Dermatologic CareParticipants 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. |
| Anti-Inflammatory Diet Only | Experimental | Dietary Supplement: Anti-Inflammatory Diet (Gluten-Free, Low-Histamine)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. |
| Anti-Inflammatory Diet with Physical Therapy | Experimental | Other: Physical Therapy ProgramParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-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. | Dietary supplement | Anti-Inflammatory Diet Only |
| Physical Therapy ProgramA 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. | Other | Anti-Inflammatory Diet with Physical Therapy |
| Standard Dermatologic CareParticipants 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. | Other | Standard Care (Control Group) |
Primary outcome
Change in Psoriasis Severity Assessed by the Pediatric Psoriasis Area and Severity Index (P-PASI)
Time frame: 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.
10 secondary outcomes
Change in High-Sensitivity C-Reactive Protein (hs-CRP) Levels
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Interleukin-6 (IL-6) Levels
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Tumor Necrosis Factor-Alpha (TNF-α) Levels
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
Time frame: Baseline, 6 weeks, and 12 weeks
Change in Functional Exercise Capacity Assessed by the Six-Minute Walk Test (6MWT)
Time frame: Baseline and 12 weeks
Change in Body Mass Index (BMI) Percentile
Time frame: Baseline, 6 weeks, and 12 weeks
Dietary Adherence Assessed by Three-Day Food Diaries
Time frame: Baseline, 6 weeks, and 12 weeks
Dietary Adherence Assessed by a 10-Point Visual Analog Scale
Time frame: Weeks 1 through 12
Physical Therapy Session Attendance Rate
Time frame: Weeks 1 through 12
Number of Participants with Adverse Events
Time frame: Weeks 1 through 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- BackgroundUpdated S2k guideline recommendations for children and adolescents with psoriasis. DERMATOLOGIE PRAXIS. 2022;32(5):39-42. Published October 25, 2022.
- Background: PubMed 27718521van Geel MJ, Otero ME, de Jong EM, van de Kerkhof PC, Seyger MM. Validation of the Simplified Psoriasis Index in Dutch children and adolescents with plaque psoriasis. Br J Dermatol. 2017 Mar;176(3):771-776. doi: 10.1111/bjd.15120. Epub 2016 Dec 8.
- BackgroundFarouk S, Aoun R, Muwafak B, Al-Darraji H, Al-Dujaili A. Lifestyle and Nutrition in Psoriasis: Key Factors in Pathogenesis and Disease Modulation. In: Psoriasis - Recent Advances in Diagnosis and Treatment. IntechOpen; 2025. doi: 10.5772/intechopen.1011490.
- Background: PubMed 39879606Perez-Bootello J, Berna-Rico E, Abbad-Jaime de Aragon C, Cova-Martin R, Goni L, Ballester-Martinez A, Jaen-Olasolo P, Mehta N, Gelfand JM, Martinez-Gonzalez MA, Gonzalez-Cantero A. Impact of the Mediterranean Diet on Patients With Psoriasis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 29;14:e64277. doi: 10.2196/64277.
- Background: PubMed 37049545De Simoni E, Rizzetto G, Molinelli E, Capodaglio I, Offidani A, Simonetti O. The Role of Diet in Children with Psoriasis: Emerging Evidence and Current Issues. Nutrients. 2023 Mar 31;15(7):1705. doi: 10.3390/nu15071705.
- ClinicalTrials.gov record for the MEDIPSO trial (Impact of the Mediterranean Diet on Patients with Psoriasis), a randomized controlled trial evaluating dietary intervention in psoriasis patients.Link provided by the sponsor.
- Full-text open-access article from the National Institutes of Health (NIH) / PubMed Central on "The Role of Diet in Children with Psoriasis: Emerging Evidence and Current Issues" (Nutrients, 2023). Provides background evidence on Mediterranean, gluten-frLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Inflammatory Diet (Gluten-Free, Low-Histamine), Physical Therapy Program and Standard Dermatologic Care in people with Psoriasis, run by Mahmoud Usama Mahmoud Ahmed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psoriasis Severity Assessed by the Pediatric Psoriasis Area and Severity Index (P-PASI) (time frame: Baseline, 6 weeks, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07736651, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.