NL-OMON49852撤回不适用
Modified Exclusive Enteral Nutrition with the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis - DIETOMICS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 35
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
- 年龄范围
- 2 至 99（—）
入选标准
- •For Patients
- •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 left sided 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 8 weeks may be enrolled.
- •2. Patients with few aphthous ulcers in the rectosigmoid only can be enrolled
排除标准
- •For patients
- •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, erythema nodosum, 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.
研究者
相似试验
招募中
不适用
Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's diseaseCrohn's DiseaseNL-OMON23154Amsterdam UMC10
已完成
不适用
Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After SurgeryCrohn Disease in RemissionNCT05214430Jinling Hospital, China84
已完成
不适用
Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's DiseaseCrohn's DiseaseNCT02843100Prof. Arie Levine63
已完成
不适用
Effects of Exclusive Enteral Nutrition on the Microbiome in Pediatric Inflammatory Bowel DiseaseInflammatory Bowel DiseasesNCT02521064McMaster Children's Hospital31
已完成
不适用
Exclusive nutritional therapy and intestinal homeostasis in pediatric inflammatory bowel diseaseK50.9Crohn disease, unspecifiedDRKS00003548Klinikum der Universität München, Dr. von Haunersches Kinderspital; Abteilung für pädiatrische Gastroenterologie und Hepatologie15