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

Ghent University Hospital0 个研究点目标入组 180 人开始时间: 2018年6月13日最近更新: 2021年3月17日

试验速览

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•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
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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
•- 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

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