NL-OMON55804招募中不适用
Potential effects of ileo-colonic delivered Vitamins or the Groningen Anti-Inflammatory Diet on course of Crohn*s Disease and the microbiome of healthy volunteers: a randomized controlled trial - The Vita-GrAID study - VITA-GrAID
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 510
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
- 18 至 99（—）
入选标准
- •Patients are eligible to participate in this study if they meet all of the
- •following criteria:
- •Signed an informed consent
- •Previously diagnosed with CD; Montreal classification: L1 (Ileal) or L3
- •(ileocolonic).
- •Low-mild disease activity (no clinically relevant symptoms and HBI<8 and CDAI
- •Evidence of mucosal inflammation (faecal calprotectin >=100 µg/g)
- •Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL
- •Leeuwarden or Isala Diaconessenhuis Meppel
- •>18 years of age
- •Able to use oral feeding and willing to undergo a dietary intervention (use
- •food out of the food boxes or use a vitamin B2/B3/C supplement or placebo)
- •Concomitant medication for CD is allowed (except for Methotrexate drugs, see
- •exclusion criteria) and will be continued and monitored during the complete
- •Healthy participants are eligible to participate in this study if they meet all
- •the following criteria:
- •Signed an informed consent
- •Never been diagnosed with IBD
- •Able to attend to the outpatient clinic of the UMCG, Martini Hospital, MCL
- •Leeuwarden or Isala Diaconessenhuis Meppel
- •>=18 year of age
- •Able to use oral feeding and willing to undergo a dietary intervention (use
- •food out of the food boxes or use a vitamin B2/B3/C supplement or placebo)
排除标准
- •Patients and healthy volunteers will be excluded from the study is they meet
- •any of the following criteria:
- •Life expectancy <12 months
- •Active Crohn's disease (HBI>=8 and CDAI>220), or expecting drug intervention
- •within 3 months
- •Colonoscopy and colon cleansing in the past 3 months;
- •Use antibiotics, probiotics (eg Yakult, Vifit, Activia) or specific
- •prebiotics supplements 3 weeks prior to the start of the intervention
- •Use of vitamin/mineral supplements 1 week prior to the start of the
- •intervention (except for vitamin D and/or calcium)
- •Use Methotrexate drugs or proton pump inhibitors
- •History of surgery:
- •o Presence of a pouch
- •o Presence of a stoma
- •Pregnant or breastfeeding
- •Swallowing disorders, not able to tolerate oral food, or use of tube feeding
- •Previously proven anaphylactic reaction to foods included in the food boxes
- •Previously diagnosed with Coeliac Disease
- •Following a vegetarian or vegan diet
研究者
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