Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical TreatmentNCT02887287
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease
An observational study of Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment, run by Sun Yat-sen University at 1 site in China.
Trial summary
The study aimed to prove EEN is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult CD patients. They plan to include about 50 patients and observe the effect of EEN. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment
- What is being tested?
- EEN
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Oct 2015
- Phase
- Observational
- 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
Study population: The detailed inclusion criteria included: 1. >18 years old 2. Patients with CD was diagnosed clinically according to previously established international criteria [9] 3. The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis. Intolerance or failure to steroids or IFX was judged by medical history 4. The disease was in an active period.
Who may be able to join
- >18 years old
- Patients with CD was diagnosed clinically according to previously established international criteria [9]
- The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis.
Who cannot join
- Patients do not macth the inclusion criteria and those who refuse to taking part in the study
Trial locations and contacts
1 site in 1 country.
China1 site
The six affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
The study aimed to prove EEN is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult CD patients. They plan to include about 50 patients and observe the effect of EEN.
- Being tested
- EEN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EENDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission after 12 weeks EEN
Measured: July 2013 to October 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJul 2013
- Primary completionOct 2015
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 Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical TreatmentStudies of the same condition, open and under way.
- More trials run by 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887287
- Sponsor's protocol ID
- E2016008
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
Publications
Yang Q, Gao X, Chen H, Li M, Wu X, Zhi M, Lan P, Hu P. Efficacy of exclusive enteral nutrition in complicated Crohn's disease. Scand J Gastroenterol. 2017 Sep;52(9):995-1001. doi: 10.1080/00365521.2017.1335770. Epub 2017 Jun 9.
PubMed 28598298
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT02887287
- Acronym / sponsor ID
- E2016008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2015 (actual)
- First posted
- 2 Sep 2016 (estimated)
- 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 study aimed to prove EEN is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult CD patients. They plan to include about 50 patients and observe the effect of EEN.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The detailed inclusion criteria included: 1. >18 years old 2. Patients with CD was diagnosed clinically according to previously established international criteria [9] 3. The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis. Intolerance or failure to steroids or IFX was judged by medical history 4. The disease was in an active period.
Key inclusion criteria (3 listed)
- >18 years old
- Patients with CD was diagnosed clinically according to previously established international criteria [9]
- The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis.
Key exclusion criteria (1 listed)
- Patients do not macth the inclusion criteria and those who refuse to taking part 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 |
|---|---|---|
| EEN | Drug | – |
Primary outcome
Clinical remission after 12 weeks EEN
Time frame: July 2013 to October 2015
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 2 Sep 2016.
- Derived from this study: PubMed 28598298Yang Q, Gao X, Chen H, Li M, Wu X, Zhi M, Lan P, Hu P. Efficacy of exclusive enteral nutrition in complicated Crohn's disease. Scand J Gastroenterol. 2017 Sep;52(9):995-1001. doi: 10.1080/00365521.2017.1335770. Epub 2017 Jun 9.
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?
An observational study of Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment, run by 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 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: finished, as of the sponsor's last update on 2 Sep 2016. 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?
Clinical remission after 12 weeks EEN (time frame: July 2013 to October 2015). 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 NCT02887287, 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 2 Sep 2016.