EUCTR2017-005059-10-BE
进行中（未招募）
1 期
Multicentric, double-blind, placebo controlled clinical trial with 5-hydroxytryptophan (5-HTP) in patients with inflammatory bowel disease in clinical and biologic remission: effect on fatigue scores - Trp-IBD
相关药物Levotonine
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Ghent University Hospital
- 入组人数
- 180
- 状态
- 进行中（未招募）
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Subject eligibility is determined according to the following criteria at enrolment:
- •\- The subject is male of or female and aged 18 to 60 yrs (inclusive)
- •\- The subject has a documented Crohn's disease or ulcerative colitis
- •\- The subject is, in the opinion of the investigator, capable of understanding and complying protocol requirements
- •\- The subject is in clinical remission over last 3 months (based on physician global assessment)
- •\- The subject is in clinical remission at day 0 based on validated scores (SCCAI \= 2 for ulcerative colitis or Harvey Bradshaw index \= 4 for Crohn’s disease).
- •\- The subject reports fatigue on a quantified scale (visual analogue scale 0 – 10\) of 5 or more
- •\- The subject is treated with biologicals and/or immunosuppressiva since at least 6 months with stable dose over last 3 months
- •\- The subject is in biologic remission at day 0: CRP \< 10 mg/l and faecal calprotectin value \< 250 mg/kg
- •Are the trial subjects under 18? no
排除标准
- •\- The subject has a clinical validated depression
- •\- The subject is taking antidepressives or neuroleptica
- •\- The subject has a psychiatric comorbidity
- •\- The subject has important comorbidities: cardiovascular disease, obstructive lung pathology, neoplasia or other
- •\- The subject has a documented Anemia (based on lab results including Hb \< 12\-13 g/dl respectively for saturation index \< 20%, Vit B12 \< 148 pmol/L or folic acid \< 6 nmol/L)
- •\- The subject has a documented hypothyreoidea (documented by a recent lab result including TSH)
- •\- The subject reports an infection within 2 weeks before inclusion
- •\- The subject reports any change in IBD medication in the last 12 weeks before inclusion
- •\- The subject was treated with oral corticosteroids during last 8 weeks before enrolment
- •\- The subject reports an ongoing pregnancy or breastfeeding
结局指标
主要结局
未指定
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