Crohn's Disease
Conditions
Keywords
exclusive enteral nutrition, active Crohn's disease, enteric fistula, intestinal stricture, intra-abdominal abscess
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTExclusive 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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Diagnosis of Crohn's disease established on the basis of overall clinical assessment, including compatible clinical history and standard endoscopic, histologic, and/or radiologic findings, as determined by the treating physician. Histologic confirmation at baseline is not required if endoscopy or biopsy is not feasible or clinically inappropriate because of severe disease, poor nutritional status, or intra-abdominal abscess/sepsis. 3. Active Crohn's disease at baseline, as determined by the treating physician. 4. Willingness to initiate and receive exclusive enteral nutrition (EEN) as the sole induction therapy as part of physician-directed routine care. 5. Presence of malnutrition or nutritional risk and clinical indication for EEN. 6. Patients with intestinal complications, including enteric fistula, intestinal stricture, and/or intra-abdominal abscess, are eligible if considered appropriate for EEN-based management by the treating physician. 7. Ability and willingness to provide written informed consent and to comply with study assessments and follow-up for 12 weeks. 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
1. Any absolute contraindication to enteral nutrition, including but not limited to gastrointestinal perforation, uncontrolled gastrointestinal bleeding, severe hemodynamic instability/shock, or other conditions where enteral feeding is not clinically appropriate. 2. Immediate need for emergency surgery at baseline. 3. Inability or unwillingness to receive EEN as the sole induction therapy at baseline. 4. Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | Baseline to Week 12 | Proportion of participants achieving clinical remission at Week 12, defined as CDAI \< 150. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response rate | Baseline to Week 12 | 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. |
| Endoscopic remission rate | Baseline to Week 12 | Proportion of participants achieving endoscopic remission at Week 12, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) \< 4. |
| Endoscopic response rate | Baseline to Week 12 | 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. |
| Mucosal healing rate | Baseline to Week 12 | Proportion of participants achieving mucosal healing at Week 12, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) \< 3. |
| Fecal calprotectin normalization rate | Baseline to Week 12 | Proportion of participants achieving normalization of fecal calprotectin (FC) at Week 12, defined as FC ≤ 250 μg/g. |
| CRP normalization rate | Baseline to Week 12 | 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. |
| Improvement in body mass index | Baseline to Week 12 | Proportion of participants achieving improvement in body mass index (BMI) at Week 12, defined as an increase from baseline. |
| Bowel ultrasound response rate | Baseline to Week 12 | 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. |
| Radiologic response rate on cross-sectional imaging | Baseline to Week 12 | 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. |
| Radiologic remission rate on cross-sectional imaging | Baseline to Week 12 | 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. |
| Stricture-related imaging response rate | Baseline to Week 12 | 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. |
| Complete stricture resolution rate on cross-sectional imaging | Baseline to Week 12 | 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). |
| Need for rescue intervention / surgery | Baseline to Week 12 | 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. |
Countries
China
Contacts
CONTACTWei Wang, MD
Outcome results
None listed