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

NCT06933264 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-18

No results posted yet for this 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.

Conditions

  • Crohn Disease

Interventions

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Universidad de Murcia

    collaborator OTHER

  • Sociedad Española de Endocrinología y Nutrición

    collaborator UNKNOWN

  • Instituto Murciano de Investigación Biosanitaria (IMIB)

    collaborator UNKNOWN

  • Hospital Universitario Virgen de la Arrixaca

    lead OTHER

Principal Investigators

  • Bruno Ramos Molina, Investigator of IMIB · Instituto Murciano de Investigación Biosanitaria (IMIB)

  • Antonio J. Ruiz Alcaraz, Investigator of IMIB · Instituto Murciano de Investigación Biosanitaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-05-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06933264 on ClinicalTrials.gov