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
- Conditions
- Inflammatory Bowel Disease (IBD)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-005059-10-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effect of oral 5-HTP on the global fatigue score self-reported by patient (VAS);Secondary Objective: - To differentiate between an effect on fatigue versus negative symptoms (including depression, anxiety and stress)<br>- To relate clinical effect on serum concentrations of 5-HTP and its metabolites<br>- To identify patient population who will benefit most of therapy;Primary end point(s): The primary endpoint is the proportion of patients obtaining a reduction of 20% in VAS (compared to baseline) after intervention.;Timepoint(s) of evaluation of this end point: week 8 and week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Changes in the FACIT-F scores<br>2. Changes in DASS scores to differentiate the effects on negative symptoms (depression, anxiety and stress)<br>3. Changes in adapted IPAQ score<br>4. Changes in serum 5-HTP by treatment<br>5. Changes in serum 5-hydroxyindoleacetic acid by treatment<br>6. Changes in serum serotonine levels by treatment<br>7. Changes in serum melatonine levels by treatment<br>8. Changes in faecal microbiome/metabolome;Timepoint(s) of evaluation of this end point: week 8 and week 16