Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease

Last updated: October 15, 2022
Sponsor: Duzce University
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04921033
EEN in ileocaecal Crohn's
  • Ages 18-75
  • All Genders

Study Summary

Inflammatory bowel diseases are chronic and progressive entities, triggered by exposure to environmental factors in individuals with a genetic background.

One of the most common environmental factors is the type of diet which is a key influencer on pathogenesis. Nutrients alter the intestinal microbiota, thus changing the intestinal permeability. The Western-type diet encompasses sugar, fat, and protein-rich products that have some deleterious effects on the intestinal microbiome compared to the plant-based Mediterranean-type diet.

Based on this fact, diet-based therapeutic efforts have been used extensively in pediatric Crohn's disease patients and there is strong evidence that exclusive enteral nutrition (EEN) is as effective as corticosteroids to induce both clinical and endoscopic remission but this treatment strategy is underutilized in adults.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects, aged between 18-75 years with a diagnosis of ileocolonicCrohn's disease (CD) confirmed using endoscopy and/or imaging technology at most 3months prior.
  • Participant or his/her legal representative have voluntarily signed and dated aninformed consent approved by and compliant with the requirements of this studyprotocol which has been approved by an Institutional Review Board (IRB)/IndependentEthics Committee (IEC) Adequate cardiac, renal, and hepatic function as determined bythe Principal Investigator and demonstrated by Screening laboratory evaluations,questionnaires, and physical examination results that do not indicate an abnormalclinical condition that would place the participant at undue risk precludeparticipation in the study.
  • Participant must be able to orally administer study medication/nutrient or have adesignee or Healthcare Professional who can assist

Exclusion

Exclusion Criteria:

  • Previous or current use of any medication for Crohn's disease such as biologics,immunomodulators (e.g., methotrexate, azathioprine, 6-mercaptopurine, JAK inhibitor,alpha-integrin), and corticosteroids
  • Presence of complications (Fistula, abscess, fibrotic disease, imminent risk ofsurgery)
  • Participants with a poorly controlled medical condition such as uncontrolled diabeteswith a documented history of recurrent infections, unstable ischemic heart disease,moderate to severe congestive heart failure (New York Heart Association [NYHA] classIII or IV), recent cerebrovascular accident, and any other condition which, in theopinion of the Investigator or the sponsor, would put the participant at risk byparticipation in the protocol
  • Participants with positive C. difficile stool assay at screening.
  • Rescue therapy with steroids, depending on the severity of the disease will beinitiated for patients in the EEN group who do not respond clinically and will beexcluded from the study. If the number of clinically unresponsive patients was greaterthan 25% of the total EEN population, the study will be stopped. Criteria for clinicalresponse are described in the "Outcome Measures" section.

Study Design

Total Participants: 256
Study Start date:
March 01, 2021
Estimated Completion Date:
January 01, 2026

Connect with a study center

  • Duzce University School of Medicine

    Duzce, 81620
    Turkey

    Active - Recruiting

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