Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Adult Patients with Crohn's Disease: Protocol for a Prospective, Interventional, Controlled, Randomized Clinical Trial.

Background: Crohn's disease (CD) is an inflammatory bowel disease in which there is an alteration in 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 necessary to restrict the intake of ultra-processed products and to promote the consumption of those with anti-inflammatory effects that improve intestinal permeability and dysbiosis. Methods: Based on previous studies conducted in other cohorts, mainly pediatric, we propose an experimental, prospective, randomized 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 intervention group will be prescribed an exclusion diet supplemented with enteral nutrition. Results: Patients in the intervention group are expected to exhibit increased lean body mass and reduced visceral fat, as measured by bioelectrical impedance analysis (BIA), alongside higher rates of clinical remission (CDAI), decreased inflammatory markers, and improved gut microbiota composition. Additionally, improvements in health-related quality of life are anticipated, as assessed by validated questionnaires. Conclusions: 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 intestinal dysbiosis, inflammatory status, and clinical and body composition markers in these patients.