Crohn'sNot yet recruiting
Corporal Composition and Gut Microbiome Modification Through Exclusion Dietary Intervention in Crohn's Disease
Not applicable · Testing Exclusion diet · 1 site · Hospital Universitario Virgen de la Arrixaca
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Exclusion diet (a dietary supplement) as a possible treatment. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 3 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 10 participants are expected to take part.
- Start date: 2025-05-01 (planned).
- Main results expected around 2026-05-31 (estimate from the record).
- 1 study site listed in Spain.
Main thing being measured
- Body composition (From enrollment to the end of study at 24 weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Hospital Universitario Virgen de la Arrixaca |
| Collaborators | Universidad de Murcia; Sociedad Española de Endocrinología y Nutrición; Instituto Murciano de Investigación Biosanitaria (IMIB) |
| Enrollment | 10 (estimated) |
| Start date | 2025-05-01 |
| Primary completion (est.) | 2026-05-31 |
| First posted | 2025-04-18 |
| Last updated | 2025-04-18 |
| 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 |
| ClinicalTrials.gov ID | NCT06933264 |
Interventions
- Exclusion diet (Dietary Supplement)
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.
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Virgen de la Arrixaca | El Palmar, Murcia | Spain |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.