TrialBridgeNCT06933264
Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Crohn's Disease
Not Yet Recruiting · Not Applicable · Hospital Universitario Virgen de la Arrixaca · registry updated 2025-04-18
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- 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
- 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.