Crohn DiseaseNCT04160325
Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery
A study testing postoperative 3-month exclusive enteral nutrition, azathioprine and normal diet in people with Crohn Disease, run by Zhu Weiming at 1 site in China.
Trial summary
for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- postoperative 3-month exclusive enteral nutrition, azathioprine and normal diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Oct 2023
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD patients who undergoing bowel resection with anastomosis
Who cannot join
- patients who had administered with immunomodulators or biological agents patients who were created stoma
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Weiming Zhu, PhD, 86-25-80863736, juwiming@nju.edu.cn
About this study
Official title: The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery
for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.
Read the detailed description
For patients with Crohn's disease(CD), whether exclusive enteral nutrition(EEN) following bowel resection and anastomosis could delay the disease recurrence remains unkown. In this study， CD patients after surgery will be divided into two groups: one group is treated with 3 months' EEN and then turn to normal diet after 3 months; the other group is given with normal diet all through. All patients will be adminstrated with oral azathioprine after surgery. Then, the rates of 1 year postoperative endoscopic recurrence will be compared between groups.
- Conditions
- Crohn Disease
- Being tested
- postoperative 3-month exclusive enteral nutrition, azathioprine, normal diet
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative 3-month exclusive enteral nutritionDietary supplement
postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months
azathioprineDrug
azathioprine
normal dietOther
normal diet
| Study group | Role | What they receive |
|---|---|---|
| 3 months exclusive enteral nutrition plus azathioprine | Experimental | patients underwent surgery in this arm will given 3 months exclusive enteral nutrition,and free diet after 3 months. All patients will be adminsrated with oral azathioprine to preventing disease recurrence. Receives: Dietary Supplement: postoperative 3-month exclusive enteral nutrition; Drug: azathioprine |
| normal diet plus azathioprine | Active comparator | patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence. Receives: Drug: azathioprine; Other: normal diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 1 year postoperative anastomotic recurrence
the 1 year postoperative anastomotic recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Jan 2018
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Weiming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Weiming, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160325
- Sponsor's protocol ID
- jinlingH201709
- Status last verified
- Oct 2023
- First submitted
- 3 Nov 2019
- Last updated
- 17 Oct 2023
- 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery
- ClinicalTrials.gov ID
- NCT04160325
- Acronym / sponsor ID
- jinlingH201709
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Zhu WeimingUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 13 Nov 2019 (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.
for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.
Detailed description
For patients with Crohn's disease(CD), whether exclusive enteral nutrition(EEN) following bowel resection and anastomosis could delay the disease recurrence remains unkown. In this study， CD patients after surgery will be divided into two groups: one group is treated with 3 months' EEN and then turn to normal diet after 3 months; the other group is given with normal diet all through. All patients will be adminstrated with oral azathioprine after surgery. Then, the rates of 1 year postoperative endoscopic recurrence will be compared between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months exclusive enteral nutrition plus azathioprine | Experimental | Dietary Supplement: postoperative 3-month exclusive enteral nutrition, Drug: azathioprinepatients underwent surgery in this arm will given 3 months exclusive enteral nutrition,and free diet after 3 months. All patients will be adminsrated with oral azathioprine to preventing disease recurrence. |
| normal diet plus azathioprine | Active comparator | Drug: azathioprine, Other: normal dietpatients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CD patients who undergoing bowel resection with anastomosis
Key exclusion criteria (1 listed)
- patients who had administered with immunomodulators or biological agents patients who were created stoma
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 |
|---|---|---|
| postoperative 3-month exclusive enteral nutritionpostoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months | Dietary supplement | 3 months exclusive enteral nutrition plus azathioprine |
| azathioprineazathioprine | Drug | 3 months exclusive enteral nutrition plus azathioprine, normal diet plus azathioprine |
| normal dietnormal diet | Other | normal diet plus azathioprine |
Primary outcome
the 1 year postoperative anastomotic recurrence
Time frame: 1 year
the 1 year postoperative anastomotic recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postoperative 3-month exclusive enteral nutrition, azathioprine and normal diet in people with Crohn Disease, run by Zhu Weiming 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 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weiming zhu (+86-025-80860036, juwiming@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 1 year postoperative anastomotic recurrence (time frame: 1 year). 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 17 Oct 2023.