Using exclusive enteral nutrition to treat ileocaecal Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of exclusive enteral nutrition (EEN) in inducing remission in adults with ileocolonic Crohn's disease. The study compares EEN, specifically using Nestle Modulen®, to standard care treatments. It aims to address the underutilization of dietary interventions in adult patients, despite evidence supporting their efficacy in pediatric cases. Participants will be closely monitored for clinical and endoscopic outcomes throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

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 of surgery)
* Participants with a poorly controlled medical condition such as uncontrolled diabetes with a documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV), recent cerebrovascular accident, and any other condition which, in the opinion of the Investigator or the sponsor, would put the participant at risk by participation in the protocol
* Participants with positive C. difficile stool assay at screening.
* Rescue therapy with steroids, depending on the severity of the disease will be initiated for patients in the EEN group who do not respond clinically and will be excluded from the study. If the number of clinically unresponsive patients was greater than 25% of the total EEN population, the study will be stopped. Criteria for clinical response are described in the "Outcome Measures" section.

Where it's running

• Duzce University School of Medicine
  Duzce, Turkey Recruiting

Study contacts

• Principal investigator: Salih Tokmak — Duzce University
• Study coordinator: Salih Tokmak
• Email: salihtokmak@duzce.edu.tr
• Phone: 0905052532698

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.