Crohn Disease, Nutrition Disorders, Surgery
Conditions
Keywords
Crohn's disease, Exclusive enteral nutrition, surgery
Brief summary
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_SUPPLEMENTpeptison liquid
CD patients requiring bowel resection and preoperative EEN were randomized to receive peptison liquid for 6 weeks.
DIETARY_SUPPLEMENTEnteral nutritional suspension
CD patients requiring bowel resection and preoperative EEN were randomized to receive enteral nutritional suspension for 6 weeks.
Sponsors
Wei Zhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. elective bowel resection for Crohn's disease; 2. preoperative diagnosis of Crohn's disease; 3. age between 18 to 65 years old; 4. malnutrition; 5. the Crohn's disease activity index over 150; 6. nasal feeding.
Exclusion criteria
1. emergency surgery; 2. preoperative exclusive enteral nutrition before three months; 3. can not tolerate enteral nutrition; 4. less than 6 weeks of exclusive enteral nutrition; 5. preoperative corticosteroids within 3 months; 6. history of gastrointestinal surgery; 7. isolated colon disease; 8. metabolic disease (diabetes, hyperthyroidism).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of CRP/ALB level | 6 weeks | The ratio of C-reactive protein to albumin level changed after exclusive enteral nutrition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | 6 weeks | The BMI level changed after exclusive enteral nutrition. |
| CDAI | 6 weeks | Crohn's disease activity index, from 0 to 600, the higher index shows more serious of CD. |
| postoperative complications | 6 weeks | The incidence of postoperative complications in two groups. |
| adverse reaction | 6 weeks | The incidence of adverse reaction during exclusive enteral nutrition. |
Countries
China
Contacts
Primary ContactWei Zhou
Backup ContactXiaolong Ge
Outcome results
None listed