Crohn's DiseaseNCT05815355
Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease
An observational study of Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Patients with Crohn's disease (CD) could develop complications such as stricture, intestinal fistula and abdominal abscess. Some CD patients had poor response to medical therapy. The efficacy of exclusive enteral nutrition (EEN) to these adult active CD patients is still unclear. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- exclusive enteral nutrition treatment group
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Sep 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: All consecutive adult active CD patients followed up in our center and had been diagnosed with disease complications including stricture, intestinal fistula, abdominal abscess or no response to drugs. Patients were recruited from July 2013 to July 2015.
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. Intolerance or failure to steroids or IFX was judged by medical history
- The disease was in an active period.
Who cannot join
- Intolerant to EEN or need emergency surgery
- The bowel stricture should mainly cause by fibrosis
About this study
Official title: Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment
Patients with Crohn's disease (CD) could develop complications such as stricture, intestinal fistula and abdominal abscess. Some CD patients had poor response to medical therapy. The efficacy of exclusive enteral nutrition (EEN) to these adult active CD patients is still unclear. The investigators aim to study the efficacy of EEN in induction of remission in adult active CD patients with complications or poor response to drugs.
Read the detailed description
Active CD patients following up in our center who had been diagnosed as complicated disease with stricture, intestinal fistula, abdominal abscess and no response to drugs, were recruited since July 2013. Patients were only offered EEN for 12 weeks without using other drugs except that patients with abscess could use antibiotic therapy with or without percutaneous drainage. The disease activity was assessed by the Crohn's disease activity index (CDAI). CDAI<150 was taken as achieving clinical remission. Demographics and clinical variables were recorded. Nutritional (body mass index, albumin) and inflammatory (High sensitivity C-reactive protein and platelet) index were evaluated at baseline, week 4 and week 12. Some patients performed colonoscopy and/or computed tomography enterography (CTE) /resonance enterography(MRE) before and after EEN. Mucosal healing was assessed under endoscopy with SES-CD and the size of abscess was detected by CTE /MRE.
- Conditions
- Crohn's Disease
- Being tested
- exclusive enteral nutrition treatment group
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exclusive enteral nutrition treatment groupDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission after 12 weeks EEN
The Crohn's disease activity index (CDAI)<150 was taken as achieving clinical remission.
Measured: July 2013 to October 2015
Mucosal healing after EEN
Mucosal healing was assessed under endoscopy with SES-CD.
Measured: July 2013 to October 2015
Secondary outcomes (4)
The high sensitivity C-reactive protein (mg/L) -Inflammatory parameter assessment
The high sensitivity C-reactive protein (mg/L) was evaluated at baseline, week 4 and week 12.
Measured: baseline, week 4 and week 12
Inflammatory parameter assessment
The platelet (10*9/L) was evaluated at baseline, week 4 and week 12.
Measured: baseline, week 4 and week 12
The body mass nutritional parameter assessment
The body mass was evaluated at baseline, week 4 and week 12.
Measured: baseline, week 4 and week 12
The albumin (g/L)- nutritional parameter assessment
The albumin (g/L) was evaluated at baseline, week 4 and week 12.
Measured: baseline, week 4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startJul 2013
- Primary completionSep 2015
- Study completionSep 2015
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 Sixth Affiliated Hospital, 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
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Peng, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815355
- Sponsor's protocol ID
- E2016008
- Status last verified
- Apr 2023
- First submitted
- 25 Sep 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. 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 With Complications or Failure of Medical Treatment
- ClinicalTrials.gov ID
- NCT05815355
- Acronym / sponsor ID
- E2016008
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Apr 2023 (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.
Patients with Crohn's disease (CD) could develop complications such as stricture, intestinal fistula and abdominal abscess. Some CD patients had poor response to medical therapy. The efficacy of exclusive enteral nutrition (EEN) to these adult active CD patients is still unclear. The investigators aim to study the efficacy of EEN in induction of remission in adult active CD patients with complications or poor response to drugs.
Detailed description
Active CD patients following up in our center who had been diagnosed as complicated disease with stricture, intestinal fistula, abdominal abscess and no response to drugs, were recruited since July 2013. Patients were only offered EEN for 12 weeks without using other drugs except that patients with abscess could use antibiotic therapy with or without percutaneous drainage. The disease activity was assessed by the Crohn's disease activity index (CDAI). CDAI<150 was taken as achieving clinical remission. Demographics and clinical variables were recorded. Nutritional (body mass index, albumin) and inflammatory (High sensitivity C-reactive protein and platelet) index were evaluated at baseline, week 4 and week 12. Some patients performed colonoscopy and/or computed tomography enterography (CTE) /resonance enterography(MRE) before and after EEN. Mucosal healing was assessed under endoscopy with SES-CD and the size of abscess was detected by CTE /MRE.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All consecutive adult active CD patients followed up in our center and had been diagnosed with disease complications including stricture, intestinal fistula, abdominal abscess or no response to drugs. Patients were recruited from July 2013 to July 2015.
Key inclusion criteria (4 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. Intolerance or failure to steroids or IFX was judged by medical history
- The disease was in an active period.
Key exclusion criteria (2 listed)
- Intolerant to EEN or need emergency surgery
- The bowel stricture should mainly cause by fibrosis
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 |
|---|---|---|
| exclusive enteral nutrition treatment group | Dietary supplement | – |
Primary outcome
Clinical remission after 12 weeks EEN
Time frame: July 2013 to October 2015
The Crohn's disease activity index (CDAI)<150 was taken as achieving clinical remission.
Mucosal healing after EEN
Time frame: July 2013 to October 2015
Mucosal healing was assessed under endoscopy with SES-CD.
4 secondary outcomes
The high sensitivity C-reactive protein (mg/L) -Inflammatory parameter assessment
Time frame: baseline, week 4 and week 12
Inflammatory parameter assessment
Time frame: baseline, week 4 and week 12
The body mass nutritional parameter assessment
Time frame: baseline, week 4 and week 12
The albumin (g/L)- nutritional parameter assessment
Time frame: baseline, week 4 and week 12
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 18 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen 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 4 inclusion and 2 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 18 Apr 2023. 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.
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). 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 18 Apr 2023.