Wei Zhou
Hangzhou, Zhejiang, 310016, China
NCT Number: NCT06587178
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310016, China
Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD. The primary outcome: the reduction rate of CRP/ALB after exclusive enteral nutrition in Crohn's disease. The other outcomes: (1) the changes in Crohn's disease activity index; (2) the tolerance of enteral nutrition; (3) the changes in body mass index; (4) postoperative complications and the incidence of stoma; (5) the rate of surgery; (6) other adverse reactions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CD patients requiring bowel resection and preoperative EEN were randomized to receive peptison liquid for 6 weeks.
Other names: Nutricia, Amsterdam, Netherlands
CD patients requiring bowel resection and preoperative EEN were randomized to receive enteral nutritional suspension for 6 weeks.
Other names: Nutricia, Amsterdam, Netherlands
Time frame: 6 weeks
The ratio of C-reactive protein to albumin level changed after exclusive enteral nutrition.
Time frame: 6 weeks
The BMI level changed after exclusive enteral nutrition.
Time frame: 6 weeks
Crohn's disease activity index, from 0 to 600, the higher index shows more serious of CD.
Time frame: 6 weeks
The incidence of postoperative complications in two groups.
Time frame: 6 weeks
The incidence of adverse reaction during exclusive enteral nutrition.
Contact information is provided by the study sponsor or research team.
Wei Zhou
CONTACT
Xiaolong Ge
CONTACT
Wei Zhou
Other
Semi-elemental Versus Polymeric Exclusive Enteral Nutrition in the Preoperative Optimization for Patients with Crohn's Disease: a Randomized Controlled Trial
Acronym: SEPEN-CD
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