Crohn Disease in RemissionNCT05214430
Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
A study testing 3 months exclusive enteral nutrition after surgery in people with Crohn Disease in Remission, run by Jinling Hospital, China at 1 site in China.
Trial summary
For patients with Crohn's diseases undergoing surgery，whether postoperative exclusive enteral nutrition(EEN) could delay the endoscopic relapse needs exploration.The trial will investigate the efficacy of postoperative EEN for maintaining disease remission. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Crohn Disease in Remission
- What is being tested?
- 3 months exclusive enteral nutrition after surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CD patients who undergoing bowel resection with anastomosis
Who cannot join
- patients who received stoma creation
Trial locations and contacts
1 site in 1 country.
China1 site
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Nanjing, Jiangsu, 210000
About this study
For patients with Crohn's diseases undergoing surgery，whether postoperative exclusive enteral nutrition(EEN) could delay the endoscopic relapse needs exploration.The trial will investigate the efficacy of postoperative EEN for maintaining disease remission.
- Conditions
- Crohn Disease in Remission
- Being tested
- 3 months exclusive enteral nutrition after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 months exclusive enteral nutrition after surgeryOther
patients underwent intestinal resection and anastomosis in this arm will given over 3 months exclusive enteral nutrition,and free diet after 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 3 months exclusive enteral nutrition after surgery | Experimental | 3 months exclusive enteral nutrition after surgery Receives: Other: 3 months exclusive enteral nutrition after surgery |
| less than 1 months exclusive enteral nutrition after surgery | Experimental | less than 1 months exclusive enteral nutrition after surgery Receives: Other: 3 months exclusive enteral nutrition after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative endoscopic recurrence
over i2b of rutgeerts score
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 posted28 Jan 2022
- Study start1 Jan 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn Disease in RemissionStudies 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
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Weiming, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214430
- Sponsor's protocol ID
- jinlingH202001
- Status last verified
- Oct 2023
- First submitted
- 26 Jan 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duan M, Lu M, Diao Y, Cao L, Wu Q, Liu Y, Gong J, Zhu W, Li Y. Azathioprine Plus Exclusive Enteral Nutrition Versus Azathioprine Monotherapy for the Prevention of Postoperative Recurrence in Patients with Crohn's Disease: An Open-Label, Single-Centre, Randomized Controlled Trial. J Crohns Colitis. 2024 Aug 6;18(7):1113-1121. doi: 10.1093/ecco-jcc/jjae015.
PubMed 38253914
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
- Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
- ClinicalTrials.gov ID
- NCT05214430
- Acronym / sponsor ID
- jinlingH202001
- Conditions
- Crohn Disease in Remission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 28 Jan 2022 (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 patients with Crohn's diseases undergoing surgery，whether postoperative exclusive enteral nutrition(EEN) could delay the endoscopic relapse needs exploration.The trial will investigate the efficacy of postoperative EEN for maintaining disease remission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months exclusive enteral nutrition after surgery | Experimental | Other: 3 months exclusive enteral nutrition after surgery3 months exclusive enteral nutrition after surgery |
| less than 1 months exclusive enteral nutrition after surgery | Experimental | Other: 3 months exclusive enteral nutrition after surgeryless than 1 months exclusive enteral nutrition after surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CD patients who undergoing bowel resection with anastomosis
Key exclusion criteria (1 listed)
- patients who received stoma creation
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 |
|---|---|---|
| 3 months exclusive enteral nutrition after surgerypatients underwent intestinal resection and anastomosis in this arm will given over 3 months exclusive enteral nutrition,and free diet after 3 months. | Other | 3 months exclusive enteral nutrition after surgery, less than 1 months exclusive enteral nutrition after surgery |
Primary outcome
postoperative endoscopic recurrence
Time frame: 1 YEAR
over i2b of rutgeerts score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 38253914Duan M, Lu M, Diao Y, Cao L, Wu Q, Liu Y, Gong J, Zhu W, Li Y. Azathioprine Plus Exclusive Enteral Nutrition Versus Azathioprine Monotherapy for the Prevention of Postoperative Recurrence in Patients with Crohn's Disease: An Open-Label, Single-Centre, Randomized Controlled Trial. J Crohns Colitis. 2024 Aug 6;18(7):1113-1121. doi: 10.1093/ecco-jcc/jjae015.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 months exclusive enteral nutrition after surgery in people with Crohn Disease in Remission, run by Jinling Hospital, China 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative endoscopic 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?
On the ClinicalTrials.gov record for NCT05214430, which also lists 1 linked publication.
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.