ClinicalTrials.gov
Cure8 trial brief
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
Procedures and surgery
Biopsy
Abscess Drainage
Fistula
Abscess
Clinical Trial Phase 1
Adult patients
Clinicians
Why This Matters
EEN is being evaluated as a non‑pharmacologic induction therapy in adults with active and complicated Crohn’s disease; results could inform whether EEN helps induce remission, improve nutrition, and impact inflammation or mucosal healing in this population.
Who Should Pay Attention
Adults with active Crohn’s disease (including those with strictures, fistulas, or intra‑abdominal abscesses), clinicians who manage IBD nutrition and medical therapy, and researchers interested in EEN, microbiome, and biomarker studies.
Study Snapshot
Story typeClinical Reference
Evidence typeClinical trial
Enrollment300 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a registered, single-center prospective observational cohort study testing exclusive enteral nutrition (EEN) as the primary induction therapy in adults with active Crohn’s disease, including patients with complicated disease (intestinal strictures, enteric fistulas, and intra‑abdominal abscesses).
Participants will start EEN at baseline and be followed for 12 weeks; the primary endpoint is clinical remission at Week 12 (CDAI <150). The protocol records EEN details (formula, route, calories), clinical and laboratory outcomes, and endoscopy when performed as routine care.
Some participants with large abscesses may receive percutaneous drainage and antibiotics if clinically indicated. The study also includes exploratory molecular work: longitudinal gut microbiome, metabolomics, transcriptomics, and candidate biomarker assessments to explore associations with clinical and nutritional response to EEN.
This is an observational, recruiting study (planned n=300) — it describes the planned design and outcomes rather than reporting results. It does not mandate other CD medications during the 12‑week EEN period except clinically necessary interventions for complications.
Keep In Mind
This is a trial registry entry describing a planned observational study; it does not report outcomes. The study is single‑center and observational, so findings will be hypothesis‑generating and may be affected by selection and treatment‑choice biases. Exploratory molecular analyses are described but should be interpreted as planned research rather than completed results.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Trial IDNCT07504510
Study typeObservational
Enrollment300 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 4, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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