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

• Status: Completed
• Trial end date: 2021-03-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: 5-Hydroxytryptophan

Criteria

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