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NCT06933264

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

Not yet recruiting NA Last updated 18 April 2025
What this trial tests

NA trial testing Exclusion diet in Crohn Disease in 10 participants. Not yet recruiting.

Timeline
1 May 2025
Primary endpoint
31 May 2026
31 December 2027

Quick facts

Lead sponsorHospital Universitario Virgen de la Arrixaca
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment10
Start date1 May 2025
Primary completion31 May 2026
Estimated completion31 December 2027
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Universitario Virgen de la Arrixaca

Who can join

18 and older, any sex, with Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

Other Hospital Universitario Virgen de la Arrixaca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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