NCT03574948已完成2 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 13
- 主要终点
- Change in Visual Analog Scale (VAS) after intervention
研究概览
简要总结
This placebo cross-over trial aims to study the effect of the oral intake of an essential amino-acid 5-OH tryptophan, the precursor of serotonin, on the fatigue scores in IBD patients in deep clinical and biological remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is male 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 immunosuppressives 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
排除标准
- •The subject has a clinical validated depression
- •The subject is taking antidepressives or neuroleptics
- •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 (biologicals and immunosuppressives) in the last 12 weeks before inclusion
- •The subject was treated with oral corticosteroids during the last 8 weeks before enrolment
- •The subject reports an ongoing pregnancy or breastfeeding
- •The subject has a history of lymphoproliferative disease or cancer other than basocellular skin cancer
- •The subject underwent surgery in the past 12 weeks prior to the screening visit
- •The subject reports a history of clinically significant drug abuse (defined as any illicit drug use) or alcohol abuse within 1 year prior to inclusion
研究组 & 干预措施
placebo oral capsule
Placebo Comparator
8 weeks placebo (2 x 1 capsule per day)
干预措施: Placebo oral capsule (Drug)
5-HTP
Experimental
8 weeks active substance 5-HTP (2 x 100 mg per day)
干预措施: 5-HTP (Drug)
结局指标
主要结局
Change in Visual Analog Scale (VAS) after intervention
时间窗: weekly, 16 weeks
Patients are asked to indicate their fatigue level on a VAS-scale from 0 to 10, where 0 represents no fatigue and where 10 indicates the patient suffers from severe fatigue.
次要结局
- Changes in short Depression Anxiety and Stress Scale (DASS21)(week 0, week 8 and week 16)
- Change in Adapted International Physical Activity Questionnaire (IPAQ)(week 0, week 8 and week 16)
- Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment(Week 0, week 8 and week 16)
- Changes in serum 5-hydroxyindoleacetic acid by treatment(Week 0, week 8 and week 16)
- Changes in serum serotonin levels by treatment(Week 0, week 8 and week 16)
- Changes in serum melatonin levels by treatment(Week 0, week 8 and week 16)
- Changes in faecal microbiome/metabolome(Week 0, week 8 and week 16)
- Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score(week 0, week 8 and week 16)
研究者
研究点 (13)
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