5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores

Inclusion Criteria: * 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 Exclusion Criteria: * 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