Crohn's DiseaseEEN-CDNCT07504510
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
An observational study of Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Exclusive Enteral Nutrition
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years.
- 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.
- Active Crohn's disease at baseline, as determined by the treating physician.
- Willingness to initiate and receive exclusive enteral nutrition (EEN) as the sole induction therapy as part of physician-directed routine care.
- Presence of malnutrition or nutritional risk and clinical indication for EEN.
- 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.
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- 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.
Who cannot join
- 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.
- Immediate need for emergency surgery at baseline.
- Inability or unwillingness to receive EEN as the sole induction therapy at baseline.
- Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Wang, MD, wangw239@mail.sysu.edu.cn
About this study
Official title: Effectiveness and Safety of Exclusive Enteral Nutrition in Adults With Active and Complicated Crohn's Disease: A Single-Center Prospective Cohort Study
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?
Read more
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Exclusive Enteral Nutrition
- Keywords
- exclusive enteral nutrition, active Crohn's disease, enteric fistula, intestinal stricture, intra-abdominal abscess
- Medical subject headings
- Crohn Disease, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive Enteral NutritionDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| EEN Cohort | 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. Receives: Dietary Supplement: Exclusive Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Proportion of participants achieving clinical remission at Week 12, defined as CDAI < 150.
Measured: Baseline to Week 12
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- ≥25% reduction in bowel wall thickness or stricture length compared with baseline, and/or
- ≥25% reduction in prestenotic dilation, without evidence of radiologic progression.
Measured: 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:
- bowel wall thickness ≤3 mm,
- normal luminal diameter without residual narrowing, and
- resolution of prestenotic dilation (<3 cm).
Measured: 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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Jun 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504510
- Sponsor's protocol ID
- 2020ZSLYEC-112
- Acronym
- EEN-CD
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Exclusive Enteral Nutrition in Adults With Active and Complicated Crohn's Disease: A Single-Center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07504510
- Acronym / sponsor ID
- EEN-CD / 2020ZSLYEC-112
- Conditions
- Crohn's Disease
- Keywords
- exclusive enteral nutrition, active Crohn's disease, enteric fistula, intestinal stricture, intra-abdominal abscess
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEN Cohort | – | Dietary Supplement: Exclusive Enteral NutritionAdults (≥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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Age ≥18 years.
- 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.
- Active Crohn's disease at baseline, as determined by the treating physician.
- Willingness to initiate and receive exclusive enteral nutrition (EEN) as the sole induction therapy as part of physician-directed routine care.
- Presence of malnutrition or nutritional risk and clinical indication for EEN.
Key exclusion criteria (4 listed)
- 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.
- Immediate need for emergency surgery at baseline.
- Inability or unwillingness to receive EEN as the sole induction therapy at baseline.
- Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exclusive Enteral NutritionExclusive 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. | Dietary supplement | EEN Cohort |
Primary outcome
Clinical remission
Time frame: Baseline to Week 12
Proportion of participants achieving clinical remission at Week 12, defined as CDAI < 150.
13 secondary outcomes
Clinical response rate
Time frame: Baseline to Week 12
Endoscopic remission rate
Time frame: Baseline to Week 12
Endoscopic response rate
Time frame: Baseline to Week 12
Mucosal healing rate
Time frame: Baseline to Week 12
Fecal calprotectin normalization rate
Time frame: Baseline to Week 12
CRP normalization rate
Time frame: Baseline to Week 12
Improvement in body mass index
Time frame: Baseline to Week 12
Bowel ultrasound response rate
Time frame: Baseline to Week 12
Radiologic response rate on cross-sectional imaging
Time frame: Baseline to Week 12
Radiologic remission rate on cross-sectional imaging
Time frame: Baseline to Week 12
Stricture-related imaging response rate
Time frame: Baseline to Week 12
Complete stricture resolution rate on cross-sectional imaging
Time frame: Baseline to Week 12
Need for rescue intervention / surgery
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Wang, MD (86-18702046420, wangw239@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.