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Clinical Trials in Spain / NCT06933264
Starting soon Not applicable

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

NCT06933264 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitario Virgen de la Arrixaca
Phase
Not applicable
Started
2025-05-01
Last updated
2025-04-18

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

Exclusion diet

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subjects of both sexes over 18 years of age. * A diagnosis of active luminal CD with small bowel involvement, with or without colonic involvement, prior to study inclusion. * Active symptoms of CD at the time of initiation of the nutritional intervention. * Active disease, defined as a Harvey-Bradshaw Index (HBI) \> 4 and an objective measure of disease activity, such as an elevated inflammatory marker (CRP \> 5 mg/L or 0.5 mg/dL, or calprotectin ≥ 250 µg/g) and/or a radiological imaging test (MR enterography or intestinal ultrasound) or an endoscopic test (ileocolonoscopy or capsule endoscopy). * Ability and willingness to adhere to one of the nutritional interventions. * Capacity to complete and sign the informed consent form. Exclusion Criteria: * Patients experiencing a severe flare that is associated with fistulizing tracts or strictures during the study period. * Hospitalized patients. * Patients with known intolerance or hypersensitivity to the components of the nu-tritional supplement Modulen IBD. * Patients following another diet or who are participating in other nutritional trials. * Patients scheduled for surgical intervention during the study period. * Patients with active malignancy. * Patients undergoing treatment with antibiotics or probiotics. * Patients with other clinical conditions that may interfere with the implementation of the nutritional interventions (such as heart disease, celiac disease, uncontrolled diabetes, active infections, tuberculosis, or a positive stool test for Clostridium dif-ficile toxin).

Primary outcome measure(s)

  • Body composition — From enrollment to the end of study at 24 weeks
    The primary objective of this clinical study is to determine the effectiveness and impact on body composition of implementing an exclusion diet for symptomatic remission in adult patients with active Crohn disease.

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario Virgen de la Arrixaca El Palmar Murcia

Other trials for the same condition

A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease Recruiting
Artificial Intelligence For Outcomes Research in Crohn's Disease: Digital Pathology Assessment of Fibrosis and Association With Patient History and Clinical Outcomes Starting soon
Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease Active, not recruiting
Immunological Characteristics of Preclinical IBD Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06933264 on ClinicalTrials.gov ↗ ← All trials in Spain