Anti Inflammatory Diet With Physical Therapy on Psoriasis

NCT07736651 | Recruiting DMC

• 1 other identifier: P.T.REC/012/006534
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Anti inflammatory diet; gluten free; low histamine; physical therapy; psoriasis; children; inflammation; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (10)

• 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

Study Arms (3)

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.

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.

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.

Other: Physical Therapy Program

Interventions

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.

Anti-Inflammatory Diet Only

Physical Therapy Program OTHER

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.

Anti-Inflammatory Diet with Physical Therapy

Standard Dermatologic Care OTHER

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.

Standard Care (Control Group)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahmoud Usama Mahmoud Ahmed: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Ad Doki, 11432, Egypt

RECRUITING

Related Publications (5)

• Updated S2k guideline recommendations for children and adolescents with psoriasis. DERMATOLOGIE PRAXIS. 2022;32(5):39-42. Published October 25, 2022.

  BACKGROUND

• 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.

  PMID: 27718521 BACKGROUND

• Farouk 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

• 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.

  PMID: 39879606 BACKGROUND

• De 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.

  PMID: 37049545 BACKGROUND

Related Links

• 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.
• 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-fr

MeSH Terms

Conditions

Psoriasis; Inflammation

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Mahmoud Usama, Lecturer

CONTACT

+201285221209; Mahmoud_usama@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Department of Physical Therapy for Paediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)