Status:
NOT_YET_RECRUITING
Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Crohn's Disease
Lead Sponsor:
Hospital Universitario Virgen de la Arrixaca
Collaborating Sponsors:
Universidad de Murcia
Sociedad Española de Endocrinología y Nutrición
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 microbio...
Detailed Description
An analysis of various dietary strategies to achieve remission of CD and reduce gastrointestinal symptoms concludes that it is necessary to restrict the intake of ultra-processed products while promot...
Eligibility Criteria
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.
- 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).
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06933264
Start Date
May 1 2025
End Date
December 31 2027
Last Update
April 18 2025
Active Locations (1)
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1
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120