An observational study in Crohn's Disease, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational
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:
Participants will:
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.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 300 is above the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years) with active Crohn's disease treated at a single center who initiate exclusive enteral nutrition (EEN) as the sole induction therapy and are followed for 12 weeks. The study population primarily includes patients with malnutrition or nutritional risk, and many have complicated disease with intestinal fistula, stricture, and/or intra-abdominal abscess.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Optional clarifying note:
In participants without histologic confirmation at baseline, the diagnosis may be further confirmed during follow-up when clinically feasible, including by endoscopic biopsy or surgical pathology.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults (≥18 years) with active Crohn's disease receiving exclusive enteral nutrition (EEN) will be enrolled and followed for 12 weeks. The cohort will mainly include patients with complicated disease, including stricturing disease, enteric fistula, and intra-abdominal abscess. EEN regimen details, adherence, clinical outcomes, inflammatory and nutritional parameters, endoscopic outcomes when available, and safety will be assessed during follow-up.
Dietary Supplement: Exclusive Enteral Nutrition
Exclusive enteral nutrition (EEN) consists of a nutritionally complete enteral formula used as the sole source of nutrition during the treatment period, without regular solid food intake except for water and protocol-permitted fluids. Caloric intake is individualized according to body weight, nutritional status, and clinical requirements. EEN is administered to induce disease remission and improve nutritional and inflammatory status in adults with active Crohn's disease, including those with complicated disease such as intestinal strictures or enteric fistulas.
Clinical remission
Proportion of participants achieving clinical remission at Week 12, defined as CDAI \< 150.
Time frame: Baseline to Week 12
Clinical response rate
Proportion of participants achieving clinical response at Week 12, defined as a decrease in Crohn's Disease Activity Index (CDAI) of at least 100 points from baseline.
Time frame: Baseline to Week 12
Endoscopic remission rate
Proportion of participants achieving endoscopic remission at Week 12, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) \< 4.
Time frame: Baseline to Week 12
Endoscopic response rate
Proportion of participants achieving endoscopic response at Week 12, defined as a reduction of at least 50% in the Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline.
Time frame: Baseline to Week 12
Mucosal healing rate
Proportion of participants achieving mucosal healing at Week 12, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) \< 3.
Time frame: Baseline to Week 12
Fecal calprotectin normalization rate
Proportion of participants achieving normalization of fecal calprotectin (FC) at Week 12, defined as FC ≤ 250 μg/g.
Time frame: Baseline to Week 12
CRP normalization rate
Proportion of participants achieving normalization of C-reactive protein (CRP) at Week 12, defined as CRP within the normal range according to local laboratory standards.
Time frame: Baseline to Week 12
Improvement in body mass index
Proportion of participants achieving improvement in body mass index (BMI) at Week 12, defined as an increase from baseline.
Time frame: Baseline to Week 12
Bowel ultrasound response rate
Proportion of participants achieving bowel ultrasound response at Week 12, defined as a reduction in bowel wall thickness and/or a decrease in bowel wall vascularity (Limberg score) compared with baseline.
Time frame: Baseline to Week 12
Radiologic response rate on cross-sectional imaging
Proportion of participants achieving radiologic response at Week 12, assessed primarily by computed tomography enterography (CTE) and, when available, magnetic resonance enterography (MRE), defined as unequivocal improvement from baseline in active transmural inflammatory findings on cross-sectional imaging, including reduction in bowel wall thickening, mural hyperenhancement, mural stratification and/or mural edema, comb sign, perienteric inflammatory change, and penetrating inflammatory complications, with no evidence of radiologic progression. In participants undergoing MRE, radiologic response may additionally be defined as a MaRIA score \<11 or an improvement of at least 25% from baseline.
Time frame: Baseline to Week 12
Radiologic remission rate on cross-sectional imaging
Proportion of participants achieving radiologic remission at Week 12, assessed primarily by CTE and, when available, MRE, defined as minimal or absent active transmural inflammatory findings on cross-sectional imaging, including absence or near-complete resolution of mural hyperenhancement, mural stratification and/or mural edema, comb sign, and perienteric inflammatory change, without radiologic progression or new penetrating inflammatory complications. In participants undergoing MRE, radiologic remission may additionally be defined as a MaRIA score \<7.
Time frame: Baseline to Week 12
Stricture-related imaging response rate
Proportion of participants with stricturing Crohn's disease achieving stricture-related imaging response at Week 12, assessed by cross-sectional imaging (CTE and/or MRE), defined as: 1. ≥25% reduction in bowel wall thickness or stricture length compared with baseline, and/or 2. ≥25% reduction in prestenotic dilation, without evidence of radiologic progression.
Time frame: Baseline to Week 12
Complete stricture resolution rate on cross-sectional imaging
Proportion of participants with stricturing Crohn's disease achieving complete stricture resolution at Week 12, assessed by cross-sectional imaging (CTE and/or MRE), defined as: 1. bowel wall thickness ≤3 mm, 2. normal luminal diameter without residual narrowing, and 3. resolution of prestenotic dilation (\<3 cm).
Time frame: Baseline to Week 12
Need for rescue intervention / surgery
Proportion of participants experiencing any rescue intervention at Week 12, defined as the occurrence of unplanned hospitalization, escalation of medical therapy, endoscopic intervention, drainage procedure, or surgery after treatment initiation. Planned baseline procedures performed before or at treatment initiation according to standard clinical management will not be counted as outcome events.
Time frame: Baseline to Week 12
Integrated microbiome, metabolomic, and transcriptomic changes during exclusive enteral nutrition treatment
Changes from baseline in microbiome composition, metabolomic profiles, and transcriptomic expression at Weeks 4, 8, and 12 during exclusive enteral nutrition treatment, assessed using stool, blood, and intestinal mucosal biopsy samples when available.
Time frame: Baseline, Week 4, Week 8, and Week 12; biopsy-based transcriptomic analyses at Baseline and Week 12 when available
Plan to share: No — Individual participant data (IPD) will not be shared because this is a single-center study involving detailed clinical, imaging, endoscopic, surgical, and pathology data from patients with complicated Crohn's disease, and there is a potential risk of participant re-identification despite de-identification. Data sharing is also subject to local ethics approval, institutional policy, and participant consent.
No publications or documents are linked to this record.
Started Jun 2020 (actual). Primary completion is estimated for Dec 2026, 78 months after the start.
Of 231 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's planned 78 months is above that.
Counting every sponsor, half of 304 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
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