ISRCTN14054186进行中（未招募）未知
The ADDapt diet in reducing Crohn's disease inflammation
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 03/02/2022:
- •1. Adults aged =16 years
- •2. Crohn's disease diagnosis (defined by standard clinical, histological and radiological criteria) of at least 6 months
- •3. Mildly active disease as defined by:
- •3.1 Defined by physician assessment that no change in medication is required
- •3.2 Faecal calprotectin >150 µg/g
- •3.3 CDAI between 150-250
- •3.4 Current body weight of =50 kg
- •3.5 Individuals able to give informed consent and willingness to participate
- •Previous participant inclusion criteria:
- •1. Adults aged > = 18 years
- •2. Crohn's disease diagnosis (defined by standard clinical, histological and radiological criteria) of at least 6 months
- •3. Mildly active disease as defined by:
- •3.1 Defined by physician assessment that no change in medication is required
- •3.2 Faecal calprotectin > 150 µg/g
- •3.3 CDAI between 150-250
- •3.4 Current body weight of > = 50 kg
- •3.5 Individuals able to give informed consent and willingness to participate
排除标准
- •1. Changes in dose to azathioprine, 6-mercaptopurine, methotrexate or anti-TNF-a agents or other biologics during the preceding 8 weeks, oral 5-ASA during the preceding four weeks. Currently receiving oral prednisolone/budesonide or discontinued within the last 4 weeks, unless they are on a stable dose of 10 mg/day or less prednisolone (3 mg or less budesonide) for at least 4 weeks with the intention to continue this long term.
- •2. Used rectal 5-ASA or rectal steroids in the preceding 4 weeks
- •3. Previous extensive bowel resection, defined as having had > 2 intestinal resections, a sub-total colectomy or documented short bowel syndrome
- •4. Poorly controlled bile acid malabsorption
- •5. Current stoma
- •6. Recent use of the following treatments: antibiotics, probiotics, prebiotic or fibre supplements in the preceding four weeks, NSAIDs during the preceding week
- •7. Full bowel preparation for a diagnostic procedure in preceding 4 weeks
- •8. Comorbidities including sepsis/fever, diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease
- •9. Exclusive enteral nutrition in the past 8 weeks
- •10. Assessed as at nutritional risk, as defined by any of the following:
- •10.1 BMI < = 18.5 kg/m2
- •10.2 Previous or current eating disorder
- •10.3 Currently receiving prescribed oral nutritional supplements
- •11. Following a restrictive diet (e.g. multiple restrictions due to numerous self-reported allergies) as judged by the dietitian
- •12. Reported pregnancy or lactation
研究者
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