5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores
- Conditions
- Crohn DiseaseUlcerative ColitisFatigueRemission
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03574948
- Lead Sponsor
- University Hospital, Ghent
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 5-HTP 5-HTP 8 weeks active substance 5-HTP (2 x 100 mg per day) placebo oral capsule Placebo oral capsule 8 weeks placebo (2 x 1 capsule per day)
- Primary Outcome Measures
Name Time Method Change in Visual Analog Scale (VAS) after intervention weekly, 16 weeks Patients are asked to indicate their fatigue level on a VAS-scale from 0 to 10, where 0 represents no fatigue and where 10 indicates the patient suffers from severe fatigue.
- Secondary Outcome Measures
Name Time Method Change in Adapted International Physical Activity Questionnaire (IPAQ) week 0, week 8 and week 16 The adapted IPAQ questionnaire measures the physical activity and will be filled in at week 0, week 8 and week 16.
Changes in short Depression Anxiety and Stress Scale (DASS21) week 0, week 8 and week 16 The questionnaire is a self-assessment that need to be completed without external help. The DASS questionnaire measures depression and anxiety and will be filled in at week 0, week 8 and week 16. The questionnaire contains 7 items per scale, the maximum score for depression, anxiety and stress will be 21. The higher the score of the questionnaire, the more the patient suffers from depression, anxiety and stress.
Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment Week 0, week 8 and week 16 The possible effect of Levotonine administration on the serum 5-HTP levels will be measured.
Changes in serum 5-hydroxyindoleacetic acid by treatment Week 0, week 8 and week 16 The possible effect of Levotonine administration on the serum 5-hydroxyindoleacetic levels will be measured.
Changes in serum serotonin levels by treatment Week 0, week 8 and week 16 The possible effect of Levotonine administration on the serum serotonin levels will be measured.
Changes in serum melatonin levels by treatment Week 0, week 8 and week 16 The possible effect of Levotonine administration on the serum melatonin levels will be measured.
Changes in faecal microbiome/metabolome Week 0, week 8 and week 16 since the intestinal bacteria can process tryptophane, changes in the faecal microbiome/metabolome can be possibly caused by the administration of levotonine.
Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score week 0, week 8 and week 16 The questionnaire is a self-assessment that need to be completed without external help. The FACIT-F questionnaire measures the fatigue of the patient and will be filled in at week 0, week 8 and week 16. The FACIT Fatigue scale ranges from 0 to 52, with high scores indicating higher levels of fatigue.
Trial Locations
- Locations (13)
AZ Damiaan
🇧🇪Oostende, Belgium
AZ Imelda
🇧🇪Bonheiden, Belgium
UZ Brussel
🇧🇪Brussel, Belgium
AZ Maria Middelares
🇧🇪Ghent, Belgium
AZ Sint-Lucas
🇧🇪Ghent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHU Namur
🇧🇪Namur, Belgium
ULB Erasme
🇧🇪Brussels, Belgium
AZ Nikolaas
🇧🇪Sint-Niklaas, Belgium
CHU Saint-Pièrre
🇧🇪Brussel, Belgium
UCL Saint-Luc
🇧🇪Brussel, Belgium
Ghent University Hospital
🇧🇪Ghent, Belgium
CHU Liège
🇧🇪Liège, Belgium