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CompletedNCT02887287Updated Sep 2, 2016

Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease

An observational study in Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-09-02.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
48
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 48 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • >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.

Exclusion criteria

Exclusion Criteria:

  • Patients do not macth the inclusion criteria and those who refuse to taking part in the study
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No

Interventions

  • DrugEEN
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What researchers measure

Primary outcomes

  1. Clinical remission after 12 weeks EEN

    Time frame: July 2013 to October 2015

07

Study locations

1 site
  • The six affiliated hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02887287
Lead sponsor
Sun Yat-sen University
Responsible party
Yanhong Deng (committee of the Sixth Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University) — Principal investigator
First posted
Sep 2, 2016
Start date
Jul 2013
Primary completion
Oct 2015
Last update
Sep 2, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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