NL-OMON23154招募中不适用
Modified Exclusive Enteral Nutrition with the Crohn’s Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis; the DIETOMICS-CD trial
Amsterdam UMC0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
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
入选标准
- •1. Established diagnosis of Crohn's disease.
- •2. Patients with mild to severe active Crohn's disease (15=PCDAI=47.5)
- •3. Ages 8-18
- •4. Duration of disease = 36 months
- •5. Active inflammation (CRP=0.6 mg/dL or ESR=20 or Calprotectin=200 mcg/gr during screening
- •6. Patients with B1, P0 uncomplicated disease at enrollment
- •7. Patients with disease defined as L1, L4, L3 or L2 limited to cecum, ascending or transverse colon or L2 with leftsided disease with terminal ileum or small bowel involvement in the past by the Paris classification (patients with macroscopic disease)
- •8. Signed informed consent
- •Inclusion criteria comments:
- •1. Patients with stable medication (IMM/5ASA) use or no medication use for the past
- •2. Patients with few aphthous ulcers in the rectosigmoid only can be enrolled as L2
排除标准
- •1. Patients with very mild disease (PCDAI 12.5-15) or very severe disease (PCDAI >47.5)
- •2. Pregnancy
- •3. Patients who have disease confined to the colon involving the descending colon, rectum or sigmoid colon and no prior history of small bowel involvement
- •4. Patients who have active extra intestinal disease (such as arthritis, uveitis, pyoderma gangresom, erythemanodosum, etc.)
- •5. Patients with complicated disease (B2, B3)
- •6. Patients with recent onset use of an immunomodulator <8 weeks, or dose change in past 8 weeks.
- •7. Patients with past or current use of biologics, or patients who currently use systemic steroids or used steroids over the last 8 weeks
- •8. Patients who have active perianal disease (active fistula or abscess)
- •9. Patients who have positive stool cultures with relevant pathogens, or positive tests for parasites or C. difficile. Stool tests are mandatory only if diarrhea is present.
- •10. Patients with fever > 38.3
- •11. Documented milk protein allergy
- •Exclusion criteria comments:
- •1. Aphthous stomatitis is not an exclusion criterion. Isolated aphthous ulcers of the rectosigmoid need not be excluded as left sided L2 only
- •2. Patient may receive a stable dose immunomodulator or start thiopurines at or after week 4 or Methotrexate at week 6, since the effect of thiopurine starts after 8 weeks and that does not affect the primary endpoint
- •remission at week 8.
- •3. Patients are allowed use of Omeprazole if ulcers or erosions are present in the stomach or duodenum.
- •4. Patients may receive antibiotics for intercurrent infections for up to 10 days with the exception of quinolones,metronidazole, rifaximin or oral vancomycin; antibiotics used must be registered in the CRF.
- •5. Patients with skin tags or fissures can be enrolled.
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