Inflammatory Bowel Disease (IBD)
Conditions
Interventions
Trade Name: Levotonine
Pharmaceutical Form: Capsule
INN or Proposed INN: OXITRIPTAN
CAS Number: 4350-09-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharm
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) - To relate clinical effect on serum concentrations of 5-HTP and its metabolites - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in the FACIT-F scores 2. Changes in DASS scores to differentiate the effects on negative symptoms (depression, anxiety and stress) 3. Changes in adapted IPAQ score 4. Changes in serum 5-HTP by treatment 5. Changes in serum 5-hydroxyindoleacetic acid by treatment 6. Changes in serum serotonine levels by treatment 7. Changes in serum melatonine levels by treatment 8. Changes in faecal microbiome/metabolome;Timepoint(s) of evaluation of this end point: week 8 and week 16 | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed