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

NCT06933264 | Not Yet Recruiting

• 1 other identifier: 2022-4-10-HCUVA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Keywords

Crohn disease; Gut microbiome; Nutrition; Exclusion diet

Outcome Measures

Primary Outcomes (1)

• Body composition

  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.

  From enrollment to the end of study at 24 weeks

Secondary Outcomes (12)

• Inflamatory parameters

  From enrollment to the end of study at 24 weeks

• Inflamatory parameters

  From enrollment to the end of study at 24 weeks

• Inflamatory parameters

  From enrollment to the end of study at 24 weeks

• Inflamatory parameters

  From enrollment to the end of study at 24 weeks

• Clinical parameters

  From enrollment to the end of study at 24 weeks

Study Arms (2)

Exclusion diet

EXPERIMENTAL

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.

Dietary Supplement: Exclusion diet

Mediterranean diet

NO INTERVENTION

Control Group: Patients will receive modifications to their pharmacological treatment alongside standard nutritional recommendations.

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.

Also known as: Experimental group

Exclusion diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of both sexes over 18 years of age.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Universitario Virgen de la Arrixaca: lead
• Universidad de Murcia: collaborator
• Sociedad Española de Endocrinología y Nutrición: collaborator
• Instituto Murciano de Investigación Biosanitaria (IMIB): collaborator

Study Sites (1)

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Elimination Diets

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Bruno Ramos Molina, Investigator of IMIB

  Instituto Murciano de Investigación Biosanitaria (IMIB)

  STUDY DIRECTOR

• Antonio J. Ruiz Alcaraz, Investigator of IMIB

  Instituto Murciano de Investigación Biosanitaria

  STUDY DIRECTOR

Central Study Contacts

R . Paloma Cano Mármol, Endocrinology and Nutrition

CONTACT

+ 34 618 35 71 53; palomacanomarmol96@gmail.com

Bruno Ramos Molina, Investigator of IMIB

CONTACT

+34 694 44 77 02; brunoramosmolina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MIR of Endocrinology and Nutrition

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 18, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

ES (1)