Journal of Pediatric Perspectives

Journal of Pediatric Perspectives

An investigation into the efficacy of nano-curcumin for the management of clinical symptoms and the alleviation of gastrointestinal inflammation in children with celiac disease: the study protocol for a pilot randomized controlled trial

Document Type : original article

Authors
1 Department of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
2 Department of Pediatric Gastroenterology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
3 MD, Graduated from Mashhad University of Medical Sciences, Mashhad, Iran
4 Department of Clinical Pharmacy, Faculty of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
5 Department of Nutrition, 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 an immune-mediated systemic disorder triggered by gluten ingestion in genetically predisposed individuals, resulting in chronic intestinal inflammation, mucosal damage, and nutrient malabsorption. Although a gluten-free diet is the primary treatment, inflammatory manifestations may persist despite dietary adherence, suggesting underlying mechanisms that predispose individuals to inflammation. Curcumin may be an effective adjunctive treatment for CD through immunomodulatory effects, including inhibition of T-cell activation and reduction of co-stimulatory signal expression on APCs. In addition, inhibition of pro-inflammatory pathways, reduction of oxidative stress, improvement of gut barrier function, and modulation of gut microbiota composition may contribute to protection against this disorder. This study aims to evaluate the impact of nano-curcumin on clinical and inflammatory markers in children with CD.

Methods: This prospective, double-blind, controlled pilot trial will be conducted at Akbar Children's Hospital, Mashhad. Thirty children with CD meeting the eligibility criteria will be randomly assigned to receive either placebo or nano-curcumin (80 mg/day) in addition to a gluten-free diet for 12 weeks. The primary outcome is gastrointestinal inflammation assessed before and after the intervention using fecal calprotectin and serum tTG-IgA and EMA-IgA levels. Secondary outcomes include clinical evaluation using the GSRS questionnaire and anthropometric measurements.

Discussion: The primary mechanism underlying CD pathogenesis is a disproportionate immune and inflammatory response to gluten. Curcumin may represent an effective adjunctive treatment for CD due to its immunomodulatory, anti-inflammatory, and antioxidant properties. This preliminary trial will provide evidence regarding the use of curcumin in CD and serve as a basis for future studies and clinical practice.
Keywords


Articles in Press, Accepted Manuscript
Available Online from 14 September 2026