Nano-curcumin for Clinical Symptoms and Gastrointestinal Inflammation in Children with Celiac Disease: A Pilot Randomized Controlled Trial Protocol

Jafari, Seyed-Ali; Molaei, Ali; Molaei, Emad; Talebi, Saeedeh; Mohammadzadeh, Mahsa; Jafari, Mahmood Reza; Sadeghi, Tahereh

doi:10.22038/jpp.2026.96514.5686

Nano-curcumin for Clinical Symptoms and Gastrointestinal Inflammation in Children with Celiac Disease: A Pilot Randomized Controlled Trial Protocol

Document Type : original article

Authors

Seyed-Ali Jafari ¹

Ali Molaei ²

Emad Molaei ³

Saeedeh Talebi ⁴

Mahsa Mohammadzadeh ⁵

Mahmood Reza Jafari ⁶

Tahereh Sadeghi ⁷

¹ Department of Pediatric Gastroenterology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

² Mashhad University of Medical Sciences, Mashhad, Iran.

³ Department of Clinical Pharmacy, Faculty of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

⁴ Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

⁵ Department of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

⁶ Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

⁷ Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.

10.22038/jpp.2026.96514.5686

Abstract

Background: Celiac disease (CD) is a chronic, systemic immune-mediated condition triggered by gluten exposure in genetically predisposed individuals and characterized by intestinal inflammation, mucosal injury, and impaired nutrient absorption. Lifelong adherence to a strict gluten-free diet remains the cornerstone of treatment, yet inflammatory and gastrointestinal manifestations may persist despite dietary adherence. Curcumin has anti-inflammatory and antioxidant properties and may modulate T-cell activation, antigen-presenting cell function, inflammatory signaling, oxidative stress, intestinal barrier integrity, and gut microbial balance. This pilot randomized controlled trial was designed to investigate whether adjunctive nano-curcumin can improve disease-related clinical manifestations and inflammatory biomarkers in children with CD.
Methods: This prospective, single-center, double-blind, placebo-controlled, parallel-group pilot trial will be conducted at Akbar Children's Hospital, Mashhad, Iran. Thirty eligible children aged 5–18 years with celiac disease of less than six months' duration will be randomly allocated in a 1:1 ratio to nano-curcumin (80 mg/day) or matched placebo for 12 weeks while receiving a gluten-free diet. The two primary outcomes are changes from baseline to week 12 in fecal calprotectin and serum tissue transglutaminase IgA (tTG-IgA). Secondary outcomes are gastrointestinal symptoms measured by the Gastrointestinal Symptom Rating Scale (GSRS) and standardized anthropometric measures. The primary analysis will use baseline-adjusted analysis of covariance (ANCOVA); logarithmic transformation will be considered for markedly right-skewed positive biomarker values. Because this is an exploratory pilot trial, the study is not powered to provide definitive evidence of efficacy.
Conclusion: This pilot trial will evaluate the feasibility and preliminary effects of adjunctive nano-curcumin on gastrointestinal symptoms and inflammatory and serological outcomes in children with newly diagnosed CD receiving a gluten-free diet. The study is intended to generate preliminary estimates of treatment effects and outcome variability rather than establish definitive clinical efficacy. Its findings may provide an empirical basis for the design of a subsequent adequately powered randomized controlled trial.
Trial registration: Iranian Registry of Clinical Trials IRCT20240721062501N1. Registered on October 19, 2024.

Keywords

Celiac disease

Curcumin

Inflammation

Immunomodulation

Pediatrics

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