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NOT YET RECRUITING
NCT06933264
NA

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

Sponsor: Hospital Universitario Virgen de la Arrixaca

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-05-01

Completion Date

2027-12-31

Last Updated

2025-04-18

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

Exclusion diet

Experimental Group: Patients will receive modifications to their pharmacological and will be assigned to an intervention consisting of an exclusion diet in conjunc-tion with supplemental enteral nutrition. This nutritional strategy will involve a progressive increase in the caloric intake derived from the diet, coupled with a corresponding reduction in supplemental enteral nutrition.

Locations (1)

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain