Crohn's DiseasePhase 4NCT04530877
Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients
A Phase 4 study testing Infliximab and Exclusive Enteral Nutrition in people with Crohn's Disease and Exclusive Enteral Nutrition, run by Children's Hospital of Fudan University.
Trial summary
prospectively compared Exclusive Enteral Nutrition with Infliximab in the clinical outcomes, mucosal healing, nutrition improvements, adverse effects and gastrointestinal microbiota changes on Chinese Children With active Crohn's Disease Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Exclusive Enteral Nutrition, Infliximab
- What is being tested?
- Infliximab and Exclusive Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients:
- Pediatric active Crohn's disease ( CD) patients who were newly diagnosed at the Children's Hospital of Fudan University from October 2020 to Sep 2022，CD was diagnosed according to the Porto criteria and based on a combination of history, physical and laboratory examination, endoscopy with histology, and imaging of the small bowel (capsule endoscopy or magnetic resonance imaging or enhanced computerized tomography).
- SES-CD>4 and PCDAI >10 at initial
- For the patients whose fecal will be analyzed shouldn't take antibiotics or probiotics within the 1.5 months prior to the study and during the treatment.
- healthy controls:
- free medical history
- had not taken antibiotics or probiotics within the 1.5 months prior to donate their fecal
Who cannot join
- patients who had gene mutation or combined with other intestinal diseases such as tuberculosis or EB infection
- for patients in the EEN group who could not finish the daily prescribed volume of formula for any reason; for the patients in the IFX group who could not finish the first 4 times IFX injection for any reason.
- patients who were administered EEN, corticosteroids, immunosuppressive drugs, or biological agents prior to the study;
- patients who could not attend consecutive follow-up sessions;
About this study
Official title: Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease
prospectively compared Exclusive Enteral Nutrition with Infliximab in the clinical outcomes, mucosal healing, nutrition improvements, adverse effects and gastrointestinal microbiota changes on Chinese Children With active Crohn's Disease
- Being tested
- Infliximab, Exclusive Enteral Nutrition
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD
Exclusive Enteral NutritionDietary supplement
the administration of a liquid formula diet with the exclusion of all other regular food for 6-8 weeks， the volume was determined according to the energy needs of the patient. All patients received high energy intakes (>110%-120% of the average requirement).
| Study group | Role | What they receive |
|---|---|---|
| Exclusive enteral nutrition | Experimental | the administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks， the volume was determined according to the energy needs of the patient. All patients received high energy intakes (>110%-120% of the average requirement). Receives: Dietary Supplement: Exclusive Enteral Nutrition |
| Infliximab | Active comparator | the participants with active CD accept anti-TNF therapy (Infliximab) at 0week, 2week, 6week, 14week. Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group
the mucosal healing was defined as Simple Endoscopic Score for CD （SES-CD ）≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe>16.
Measured: at the end of 8 week of treatment.
the number of patients who reach mucosal healing at the end of treatment in Infliximab group
the mucosal healing was defined as Simple Endoscopic Score for CD （SES-CD ）≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe>16.
Measured: at the end of 14 week of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Oct 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Why it stopped: no funding
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 Children's Hospital of Fudan 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
- Investigators
- Ying Huang, Dr, Study chair, Department of Gastroenterology, Pediatric Inflammatory Bowel Disease Research Center, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530877
- Sponsor's protocol ID
- twj01
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT04530877
- Acronym / sponsor ID
- twj01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Aug 2020 (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.
prospectively compared Exclusive Enteral Nutrition with Infliximab in the clinical outcomes, mucosal healing, nutrition improvements, adverse effects and gastrointestinal microbiota changes on Chinese Children With active Crohn's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusive enteral nutrition | Experimental | Dietary Supplement: Exclusive Enteral Nutritionthe administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks， the volume was determined according to the energy needs of the patient. All patients received high energy intakes (>110%-120% of the average requirement). |
| Infliximab | Active comparator | Biological: Infliximabthe participants with active CD accept anti-TNF therapy (Infliximab) at 0week, 2week, 6week, 14week. Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Pediatric active Crohn's disease ( CD) patients who were newly diagnosed at the Children's Hospital of Fudan University from October 2020 to Sep 2022，CD was diagnosed according to the Porto criteria and based on a combination of history, physical and laboratory examination, endoscopy with histology, and imaging of the small bowel (capsule endoscopy or magnetic resonance imaging or enhanced computerized tomography).
- SES-CD>4 and PCDAI >10 at initial
- For the patients whose fecal will be analyzed shouldn't take antibiotics or probiotics within the 1.5 months prior to the study and during the treatment.
- free medical history
- had not taken antibiotics or probiotics within the 1.5 months prior to donate their fecal
Key exclusion criteria (4 listed)
- patients who had gene mutation or combined with other intestinal diseases such as tuberculosis or EB infection
- for patients in the EEN group who could not finish the daily prescribed volume of formula for any reason; for the patients in the IFX group who could not finish the first 4 times IFX injection for any reason.
- patients who were administered EEN, corticosteroids, immunosuppressive drugs, or biological agents prior to the study;
- patients who could not attend consecutive follow-up sessions;
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 |
|---|---|---|
| InfliximabInfliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD | Biological | Infliximab |
| Exclusive Enteral Nutritionthe administration of a liquid formula diet with the exclusion of all other regular food for 6-8 weeks， the volume was determined according to the energy needs of the patient. All patients received high energy intakes (>110%-120% of the average requirement). | Dietary supplement | Exclusive enteral nutrition |
Primary outcome
the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group
Time frame: at the end of 8 week of treatment.
the mucosal healing was defined as Simple Endoscopic Score for CD （SES-CD ）≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe>16.
the number of patients who reach mucosal healing at the end of treatment in Infliximab group
Time frame: at the end of 14 week of treatment.
the mucosal healing was defined as Simple Endoscopic Score for CD （SES-CD ）≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe>16.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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. This study is not recruiting at the moment.
Ying Huang, Dr study chair
Department of Gastroenterology, Pediatric Inflammatory Bowel Disease Research Center, Children's Hospital of Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab and Exclusive Enteral Nutrition in people with Crohn's Disease and Exclusive Enteral Nutrition, run by Children's Hospital of Fudan University.
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 7 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: withdrawn, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group (time frame: at the end of 8 week of treatment.). The study lists 2 primary outcomes in all. 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 9 Aug 2022.