Crohn DiseaseCDNCT06673134
Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease
An observational study of Crohn Disease, run by Tongji Hospital at 1 site in China.
Trial summary
To evaluate the clinical manifestations, treatment options, and improved clinical outcomeof children with Crohn's disease in real-world Settings: (1) analysis of clinical manifestations; (2) probability of using the same treatment options; (3) Clinical outcome; Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- enteral nutrition, Immunotherapy and biological agents
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 24 Jul 2028
- How long will I take part?
- 3 Years
- 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 1 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: 100
Who may be able to join
- Children under 17 years old;
- Children with a definite diagnosis of Crohn's disease;
- Patients and their guardians must sign informed consent;
Who cannot join
- Other conditions deemed inappropriate by the doctor to participate in the study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Registry Study and Clinical Observation of Children With Crohn's Disease
To evaluate the clinical manifestations, treatment options, and improved clinical outcomeof children with Crohn's disease in real-world Settings: (1) analysis of clinical manifestations; (2) probability of using the same treatment options; (3) Clinical outcome;
Read the detailed description
This study will aim to enroll approximately 100 patients with Crohn Disease (CD). All patients who have CD will be evaluated at the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Patients who are eligible for the study will be identified during these regularly scheduled clinic visits. Patients and guardians who express interest will be set up for a meeting with a clinical research coordinator who will go over the study in detail and will obtain informed consent. Before the therapeutic intervention，stool samples will be checked for ova and parasites, C. difficile toxin and fecal calprotectin (FCP). Serum tests will include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Anti-nuclear antibodies (ANA), complete blood cell count, HIV, screening for Hepatitis A, B, C (hep A IgM, hep B surface antigen and antibody, Hep C antibody), and creatinine. Fecal tests included 16S rDNA flora detection and metabolite detection. Patients with CD will undergo colonoscopy, which is considered part of standard of care for patients with ongoing inflammation and is not considered a study procedure.
Dynamic monitoring follow-up up to 102 weeks, dynamic assessment of relevant indicators, such as ESR, CRP, FCP and endoscopy, etc. This study is an observational study, without intervention in the treatment of patients. Patients will accept the treatment plan formulated by the attending physician. Treatment options include: enteral nutrition (EEN/ PEN, reason, route of administration, dose, course of treatment); glucocorticoids (reason, route of administration, dose, course of treatment); immunosuppressants (reason, route of administration, dose, course of treatment); biologics (including domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd)) (dose, duration, effectiveness, safety, and economy); fecal microbiota transplantation (cause, transplantation routes, capsule fecal transplants, dose, course of treatment); the medical costs and resource consumption of the treatment of Crohn's disease in children. The difference of efficacy of the above treatment schemes was recorded, the treatment outcome was compared, and the transformation of treatment schemes was discussed. Researchers and patients will truthfully register the corresponding data generated by clinical practice from the doctors and patients respectively, collect the laboratory examination and evaluation data of doctors during the visit, and combine the hospital visit and electronic information system. Statistical analysis was performed after follow-up.
- Conditions
- Crohn Disease
- Being tested
- enteral nutrition, Immunotherapy, biological agents, Glucocorticoids, fecal microbiota transplantation
- Keywords
- Corticosteroids, immunosuppressants, biological agents;, Exclusive enteral nutrition;, pediatric
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionDrug
Also called nutrition
exclusive enteral nutrition therapy or Partial enteral nutrition
ImmunotherapyDrug
Also called immunosuppressor
Immunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc
biological agentsDrug
Also called biotherapy
Inflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc
GlucocorticoidsDrug
Also called glucocorticoid
Glucocorticoids treatments are given
fecal microbiota transplantationOther
Also called Flora transplantation
Fecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc
| Study group | Role | What they receive |
|---|---|---|
| enteral nutrition group | enteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition Receives: Drug: Immunotherapy; Drug: biological agents; Drug: Glucocorticoids; Other: fecal microbiota transplantation | |
| Glucocorticoid group | Glucocorticoid therapy Receives: Drug: enteral nutrition; Drug: biological agents; Other: fecal microbiota transplantation | |
| Immunosuppressive group | Immunosuppressive therapy Receives: Drug: enteral nutrition; Drug: biological agents; Other: fecal microbiota transplantation | |
| Fecal Microbiota Transplantation group | Fecal Microbiota Transplantation therapy Receives: Drug: enteral nutrition; Drug: Immunotherapy; Drug: biological agents; Drug: Glucocorticoids | |
| Biologics group | Biologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd). Receives: Drug: enteral nutrition; Drug: Immunotherapy; Drug: Glucocorticoids; Other: fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the clinical manifestations, treatment options, and clinical outcomes of Crohn's disease in children in real-world Settings
14 weeks clinical response rate.
Measured: 14 weeks
Secondary outcomes (8)
Clinical remission of different treatment regimens
Clinical remission rates at 14 and 54 weeks ( Pediatric Crohn's Disease Activity Index (PCDAI)≤10, PCDAI<10.0 was defined as the stage of clinical remission, 10.0~27.5 as the stage of clinical mild activity, 30.0~37.5 as the stage of clinical moderate activity, and 40.0~100.0 as the stage of clinical severe activity.)
Measured: 14 and 54 weeks
Clinical response of different treatment regimens
Clinical response rate at 54 weeks (PCDAI reduction ≥15 points and total PCDAI≤30 points)
Measured: 54 weeks
Endoscopic response of different treatment regimens
Endoscopic response rate at 14 and 54 weeks ((Simple Endoscopic Score for CD (SES-CD)≤2(the higher the score, the more severe the disease, heavy activity (SES-CD): >15 points) )
Measured: 14 and 54 weeks
Mucosal healing of different treatment regimens
Mucosal healing rate at 14 and 54 weeks ((Simple Endoscopic Score for CD (SES-CD)=0 (the higher the score, the more severe the disease, heavy activity (SES-CD): >15 points) );
Measured: 14 and 54 weeks
C-reactive protein of different treatment regimens
Changes of serum C-reactive protein from baseline at 14 and 54 weeks;
Measured: 14 and 54 weeks
Erythrocyte sedimentation rate of different treatment regimens
Changes of serum erythrocyte sedimentation rate from baseline at 14 and 54 weeks;
Measured: 14 and 54 weeks
Fecal calprotectin of different treatment regimens
Changes of serum fecal calprotectin from baseline at 14 and 54 weeks;
Measured: 14 and 54 weeks
Intestinal flora of different treatment regimens
Changes in intestinal flora from baseline at 14 and 54 weeks; Fecal 16S rDNA or metagenome sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods
Measured: 14 and 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Dec 2023
- Primary completion24 Jul 2026 (estimated)
- Study completion24 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biao Zou, Tongji Hospital
- Investigators
- Zhihua Huang Huang, Pro, Study director, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673134
- Sponsor's protocol ID
- 63639582
- Acronym
- CD
- Status last verified
- Sep 2025
- First submitted
- 26 Oct 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Study Protocol has been uploaded ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry Study and Clinical Observation of Children With Crohn's Disease
- ClinicalTrials.gov ID
- NCT06673134
- Acronym / sponsor ID
- CD / 63639582
- Conditions
- Crohn Disease
- Keywords
- Corticosteroids, immunosuppressants, biological agents;, Exclusive enteral nutrition;, pediatric
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 24 Jul 2028 (estimated)
- First posted
- 4 Nov 2024 (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.
To evaluate the clinical manifestations, treatment options, and improved clinical outcomeof children with Crohn's disease in real-world Settings: (1) analysis of clinical manifestations; (2) probability of using the same treatment options; (3) Clinical outcome;
Detailed description
This study will aim to enroll approximately 100 patients with Crohn Disease (CD). All patients who have CD will be evaluated at the Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Patients who are eligible for the study will be identified during these regularly scheduled clinic visits. Patients and guardians who express interest will be set up for a meeting with a clinical research coordinator who will go over the study in detail and will obtain informed consent. Before the therapeutic intervention，stool samples will be checked for ova and parasites, C. difficile toxin and fecal calprotectin (FCP). Serum tests will include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Anti-nuclear antibodies (ANA), complete blood cell count, HIV, screening for Hepatitis A, B, C (hep A IgM, hep B surface antigen and antibody, Hep C antibody), and creatinine. Fecal tests included 16S rDNA flora detection and metabolite detection. Patients with CD will undergo colonoscopy, which is considered part of standard of care for patients with ongoing inflammation and is not considered a study procedure.
Dynamic monitoring follow-up up to 102 weeks, dynamic assessment of relevant indicators, such as ESR, CRP, FCP and endoscopy, etc. This study is an observational study, without intervention in the treatment of patients. Patients will accept the treatment plan formulated by the attending physician. Treatment options include: enteral nutrition (EEN/ PEN, reason, route of administration, dose, course of treatment); glucocorticoids (reason, route of administration, dose, course of treatment); immunosuppressants (reason, route of administration, dose, course of treatment); biologics (including domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd)) (dose, duration, effectiveness, safety, and economy); fecal microbiota transplantation (cause, transplantation routes, capsule fecal transplants, dose, course of treatment); the medical costs and resource consumption of the treatment of Crohn's disease in children. The difference of efficacy of the above treatment schemes was recorded, the treatment outcome was compared, and the transformation of treatment schemes was discussed. Researchers and patients will truthfully register the corresponding data generated by clinical practice from the doctors and patients respectively, collect the laboratory examination and evaluation data of doctors during the visit, and combine the hospital visit and electronic information system. Statistical analysis was performed after follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| enteral nutrition group | – | Drug: Immunotherapy, Drug: biological agents, Drug: Glucocorticoids, Other: fecal microbiota transplantationenteral nutrition therapy, including exclusive enteral nutrition and Partial enteral nutrition |
| Glucocorticoid group | – | Drug: enteral nutrition, Drug: biological agents, Other: fecal microbiota transplantationGlucocorticoid therapy |
| Immunosuppressive group | – | Drug: enteral nutrition, Drug: biological agents, Other: fecal microbiota transplantationImmunosuppressive therapy |
| Fecal Microbiota Transplantation group | – | Drug: enteral nutrition, Drug: Immunotherapy, Drug: biological agents, Drug: GlucocorticoidsFecal Microbiota Transplantation therapy |
| Biologics group | – | Drug: enteral nutrition, Drug: Immunotherapy, Drug: Glucocorticoids, Other: fecal microbiota transplantationBiologics therapy, Including various types of biological agents, as well as domestic biological agents (Taizhou Mabtech Pharmaceutical Co.,Ltd). |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 100
Key inclusion criteria (3 listed)
- Children under 17 years old;
- Children with a definite diagnosis of Crohn's disease;
- Patients and their guardians must sign informed consent;
Key exclusion criteria (1 listed)
- Other conditions deemed inappropriate by the doctor to participate in the study;
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 |
|---|---|---|
| enteral nutritionAlso: nutritionexclusive enteral nutrition therapy or Partial enteral nutrition | Drug | Biologics group, Fecal Microbiota Transplantation group, Glucocorticoid group, Immunosuppressive group |
| ImmunotherapyAlso: immunosuppressorImmunosuppressants therapy, Including thalidomide, azathioprine, methotrexate, etc | Drug | Biologics group, Fecal Microbiota Transplantation group, enteral nutrition group |
| biological agentsAlso: biotherapyInflixima , domestic infliximab (Taizhou Mabtech Pharmaceutical Co.,Ltd) and Adalimumab , etc | Drug | Fecal Microbiota Transplantation group, Glucocorticoid group, Immunosuppressive group, enteral nutrition group |
| GlucocorticoidsAlso: glucocorticoidGlucocorticoids treatments are given | Drug | Biologics group, Fecal Microbiota Transplantation group, enteral nutrition group |
| fecal microbiota transplantationAlso: Flora transplantationFecal bacteria transplantation treatment, transplantation routes include enema, TET route, capsule fecal bacteria route, etc | Other | Biologics group, Glucocorticoid group, Immunosuppressive group, enteral nutrition group |
Primary outcome
To evaluate the clinical manifestations, treatment options, and clinical outcomes of Crohn's disease in children in real-world Settings
Time frame: 14 weeks
14 weeks clinical response rate.
8 secondary outcomes
Clinical remission of different treatment regimens
Time frame: 14 and 54 weeks
Clinical response of different treatment regimens
Time frame: 54 weeks
Endoscopic response of different treatment regimens
Time frame: 14 and 54 weeks
Mucosal healing of different treatment regimens
Time frame: 14 and 54 weeks
C-reactive protein of different treatment regimens
Time frame: 14 and 54 weeks
Erythrocyte sedimentation rate of different treatment regimens
Time frame: 14 and 54 weeks
Fecal calprotectin of different treatment regimens
Time frame: 14 and 54 weeks
Intestinal flora of different treatment regimens
Time frame: 14 and 54 weeks
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 Sep 2025.
- Mainly the incidence of IBDLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The Study Protocol has been uploaded ClinicalTrials.gov
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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.
Zhihua Huang Huang, Pro study director
Huazhong University of Science and Technology
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 Disease, run by Tongji Hospital 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. 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?
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?
To evaluate the clinical manifestations, treatment options, and clinical outcomes of Crohn's disease in children in real-world Settings (time frame: 14 weeks). 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 Sep 2025.