NL-OMON28957招募中不适用
A randomized controlled trial to investigate the efficacy of a multispecies probiotic supplement (Ecologic® BARRIER) on symptoms of fatigue in subjects with Inflammatory Bowel Disease
Winclove B.V.0 个研究点目标入组 230 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 230
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
- •Subjects between the ages of 18 and 65 years old.
- •Subjects diagnosed with Crohn’s disease or Ulcerative Colitis.
- •Subjects with a score of 4 or higher on the Chalder Fatigue Questionnaire.
排除标准
- •Subjects with active inflammation. Disease has to be in remission defined as CRP = 10 mg/l, leucocytes between 4.0-10.0 10E9/l and calprotectin levels of = 100 µg/g.
- •Subjects with abnormal laboratory values, including but not limited to hemoglobin, vitamin B12 and folic acid levels. These need to be corrected and retested before entering the study.
- •Subjects who used probiotics (including probiotic-containing products such as Yakult, Actimel, etc), antibiotics or Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) in the 4 weeks prior to the screening visit, or are planning to do so during the study.
- •Subjects with local manifestation of IBD for which surgery might be indicated or which could confound the evaluation of efficacy.
- •Subjects who have had placement of a stoma or pouch.
- •Subjects who are pregnant, lactating or planning pregnancy while enrolled in the study.
- •Subjects who are unsuitable for inclusion in the study in the opinion of the investigator for any reason that may compromise the subject’s safety or confound data interpretation.
研究者
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