Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Crohn's Disease

Crohn's disease (CD) is an inflammatory bowel disease in which there is an alteration of the homeostasis and functionality of the intestinal mucosa accompanied by a dysbiosis of the commensal microbiota. The analysis of different dietary strategies to achieve CD remission and reduce gastrointestinal symptoms concludes that it is nec-essary to restrict the intake of ultra-processed products and to promote the consump-tion of those with anti-inflammatory effects that improve intestinal permeability and dysbiosis. Based on previous studies conducted in other cohorts, mainly paediatric, we propose an experimental, prospective, randomised study in patients with active CD who do not show improvement with conventional pharmacological treatment. The control group will receive standard nutritional recommendations while the interven-tion group will be prescribed an exclusion diet supplemented with enteral nutrition. In the present project we plan to conduct a detailed study to determine the potential of the exclusion diet for the treatment and remission of CD in adult patients, with the hypothesis that this nutritional intervention will be able to modify and improve intes-tinal dysbiosis, inflammatory status and clinical and body composition markers in these patients.

NCT Number	NCT06933264
Lead Sponsor	Hospital Universitario Virgen de la Arrixaca Collaborators: Universidad de Murcia, Sociedad Española de Endocrinología y Nutrición, Instituto Murciano de Investigación Biosanitaria (IMIB)
Conditions	Crohn Disease
Enrollment	10 participants
Start Date	2025-05-01
Primary Completion	2026-05-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-18