Overview
The goal of this observational study is to evaluate the effectiveness and safety of exclusive enteral nutrition (EEN) in adults with active Crohn's disease (CD), particularly in patients with complicated disease such as stricturing disease, enteric fistula, and intra-abdominal abscess. The main questions it aims to answer are:
- What is the clinical remission rate at Week 12 in adults with active CD treated with EEN?
- How does EEN affect clinical response, endoscopic outcomes, inflammatory markers, nutritional status, BMI, and safety during follow-up?
Participants will:
- start EEN at baseline and be followed through Week 12;
- receive EEN as the main treatment approach during the study period;
- complete clinical, laboratory, nutritional, and safety assessments at prespecified follow-up visits;
- undergo endoscopic assessment when endoscopy is performed as part of routine care; and
- if clinically indicated, some participants with large intra-abdominal abscesses may receive percutaneous drainage and necessary antibiotic treatment.
Description
This is a single-center, prospective observational cohort study in adults with active Crohn's disease (CD) who are treated with exclusive enteral nutrition (EEN) during the study period. The study is designed to evaluate the effectiveness and safety of EEN in adult patients with active CD, with a focus on patients with complicated disease, including stricturing disease, enteric fistula, and intra-abdominal abscess.
Eligible participants will be enrolled at the time EEN is initiated (baseline) and followed through Week 12. EEN will serve as the main treatment approach during the study period. In general, no other therapeutic medications for CD will be used. However, for some participants with large intra-abdominal abscesses, percutaneous drainage and necessary antibiotic treatment may be provided when clinically indicated. EEN-related management, including formula type, administration route, caloric targets, and duration, will be recorded.
The primary observation time point is Week 12. The primary endpoint is the clinical remission rate at Week 12. Secondary endpoints include the clinical response rate, endoscopic remission rate, endoscopic response rate, mucosal healing rate, proportion of participants achieving normalization of inflammatory markers, and improvement in body mass index (BMI). Endoscopic outcomes will be assessed when endoscopy is performed as part of routine care. Clinical, laboratory, nutritional, and safety assessments will be collected at prespecified follow-up visits.
Exploratory endpoints include longitudinal changes in the gut microbiome, metabolomic profiles, transcriptomic features, and candidate molecular biomarkers, as well as their associations with clinical and nutritional improvement after EEN treatment.
Eligibility
Inclusion Criteria:
- Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:
- Coronary artery disease (CAD):
- Previous or recent documented type I myocardial infarction \*(if not specified, will be assumed as type I)
- History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
- History of obstructive CAD (\>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography
- Peripheral arterial disease (PAD):
- Previous or recent acute ischemic limb event (\>7 days prior)
- History of previous endovascular/surgical lower or upper extremities revascularization for an atherosclerotic cause
- History of ulcer or lower extremities amputation due to ASCVD.
- Carotid arterial diseases:
- History of previous endovascular/surgical carotid artery revascularization for atherosclerotic causes
- History of \> 50% carotid artery stenosis based on documented imaging tests (Duplex US, CT angiography, magnetic resonance angiography, or conventional angiography)
- Ischemic stroke:
- History of recent or previous documented ischemic stroke not due to atrial fibrillation, endocarditis, or systemic hypoperfusion/hypotension, being treated with low-dose aspirin
- Coronary artery disease (CAD):
- Inhabitant of Tehran province
- Willing to participate and able to provide written informed consent
Exclusion Criteria:
- Being within 72 days of acute/unstable atherosclerotic cardiovascular events (acute myocardial infarction, acute limb event, and acute ischemic stroke), or within 72 hours of revascularization.
- Patients receiving triple antithrombotic therapy
- History of upper gastrointestinal bleeding within the past 30 days
- History of intracranial hemorrhage within the past 30 days
- End-stage kidney disease with estimated creatinine clearance \< 15 mL/min, or undergoing hemodialysis or peritoneal dialysis
- Known comorbidities associated with poor prognosis (e.g., metastatic cancer) in conjunction with an estimated life expectancy of less than one year according to the treating clinician
- Any other conditions that make the participants unsuitable for recruitment or follow-up (e.g., illiteracy)
- Not having aspirin as part of the planned durable treatment regimen
- Inability to receive/read text messages/phone calls by personal mobile phone (or that of a caregiver who lives with the patient and is willing to relay messages)
- The full list of exclusion criteria is provided in the study protocol
