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 个研究点目标入组 7 人开始时间: 2014年1月31日最近更新: 2020年10月19日

试验速览

暂无简介。

•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

•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
•11. Taking any medications with the potential to influence gastrointestinal symptoms unless taking a long-term stable dose that is unlikely to change or stop during the trial
•12. Currently receiving oral nutritional supplements, enteral or parenteral nutrition, or having received dietary counselling or oral nutritional supplements, enteral or parenteral nutrition, in the previous 3 months prior to study commencement
•13. Non fluent English

发起方

King's College London (UK)