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

NCT05815355 | Completed

• 1 other identifier: E2016008
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (2)

• Clinical remission after 12 weeks EEN

  The Crohn's disease activity index (CDAI)\<150 was taken as achieving clinical remission.

  July 2013 to October 2015

• Mucosal healing after EEN

  Mucosal healing was assessed under endoscopy with SES-CD.

  July 2013 to October 2015

Secondary Outcomes (4)

• The high sensitivity C-reactive protein (mg/L) -Inflammatory parameter assessment

  baseline, week 4 and week 12

• Inflammatory parameter assessment

  baseline, week 4 and week 12

• The body mass nutritional parameter assessment

  baseline, week 4 and week 12

• The albumin (g/L)- nutritional parameter assessment

  baseline, week 4 and week 12

Interventions

exclusive enteral nutrition treatment group DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• \>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.

You may not qualify if:

• Intolerant to EEN or need emergency surgery
• The bowel stricture should mainly cause by fibrosis

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: April 18, 2023
• Study Start: July 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 18, 2023

Record last verified: 2023-04