Semi-elemental Versus Polymeric EEN in the Preoperative Optimization for Patients with CD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: peptison liquid, Enteral nutritional suspension.
- Who it may be relevant to
- Registry conditions: Crohn Disease, Nutrition Disorders, Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Semi-elemental Versus Polymeric Exclusive Enteral Nutrition in the Preoperative Optimization for Patients with Crohn's Disease: a Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement peptison liquid
CD patients requiring bowel resection and preoperative EEN were randomized to receive peptison liquid for 6 weeks. - Dietary supplement Enteral nutritional suspension
CD patients requiring bowel resection and preoperative EEN were randomized to receive enteral nutritional suspension for 6 weeks.
Primary outcome measures
- The change of CRP/ALB level [Time frame: 6 weeks]
Secondary outcome measures (4)
- BMI [Time frame: 6 weeks]
- CDAI [Time frame: 6 weeks]
- postoperative complications [Time frame: 6 weeks]
- adverse reaction [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- elective bowel resection for Crohn's disease;
- preoperative diagnosis of Crohn's disease;
- age between 18 to 65 years old;
- malnutrition;
- the Crohn's disease activity index over 150;
- nasal feeding.
Exclusion criteria
- emergency surgery;
- preoperative exclusive enteral nutrition before three months;
- can not tolerate enteral nutrition;
- less than 6 weeks of exclusive enteral nutrition;
- preoperative corticosteroids within 3 months;
- history of gastrointestinal surgery;
- isolated colon disease;
- metabolic disease (diabetes, hyperthyroidism).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Wei Zhou — Hangzhou
Identifiers
NCT: NCT06587178 · 20210323-11