Using exclusive enteral nutrition to treat ileocaecal Crohn's disease
Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease (XENIC): an Open-label, Multicenter, Prospective, Randomized Clinical Trial
PHASE3 · Duzce University · NCT04921033
This study tests whether a special diet called exclusive enteral nutrition can help adults with ileocolonic Crohn's disease feel better and achieve remission compared to standard treatments.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Duzce University (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Duzce) |
| Trial ID | NCT04921033 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a recent diagnosis of ileocolonic Crohn's disease confirmed by endoscopy or imaging.
Not a fit: Patients with contraindications to enteral nutrition or those currently on medications that may interfere with the study will not benefit.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for adults with Crohn's disease, potentially reducing reliance on corticosteroids.
How similar studies have performed: Previous studies have shown that exclusive enteral nutrition is effective in pediatric Crohn's disease, but its application in adults remains less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Duzce
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, Nutrient, Excess, Remission/Regression, enteral nutrition, induction of remission, Crohn's disease