ISRCTN50980108
Completed
未知
Detecting and managing undernutrition in adults with inactive Crohn's Disease: feasibility randomised comparative trial of oral nutritional support
King's College London (UK)0 sites7 target enrollmentJanuary 31, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- King's College London (UK)
- Enrollment
- 7
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men and women aged \=18 years
- •2\. Diagnosis of Crohn's disease for duration of at least 6 months confirmed by standard clinical, histological and radiological criteria
- •3\. Crohn's disease in remission as defined by Harvey Bradshaw score of \< 5
- •4\. Stable medications (see exclusion criteria), no recent surgery (see exclusion criteria) and stable symptoms for at least 2 months
- •5\. BMI \< 20 kg/m2
- •6\. A willingness to participate
- •7\. Individuals able to give informed consent
Exclusion Criteria
- •1\. Patients with active Crohn's disease
- •2\. Use of the following treatments: antibiotics, non\-steroidal anti\-inflammatory drugs (NSAIDs) during the preceding week
- •3\. Currently taking steroids
- •4\. Recent changes in dose to the following treatments: azathioprine, 6\-mercaptopurine, methotrexate or a\-TNF agents during the preceding 12 weeks, oral 5\-aminosalicylate (5\-ASA) or steroids during the preceding 4 weeks
- •5\. Previous pan\-proctocolectomy, pure perianal disease or short bowel syndrome
- •6\. Stenotic disease
- •7\. Sepsis or fever
- •8\. Diabetes or coeliac disease (by serology and/or duodenal biopsy)
- •9\. Other concomitant serious comorbidity e.g. significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease
- •10\. Pregnancy or lactation
Outcomes
Primary Outcomes
Not specified
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