E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammatory Bowel Disease (IBD) |
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E.1.1.1 | Medical condition in easily understood language |
Inflammatory Bowel Disease (IBD) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the effect of oral 5-HTP on the global fatigue score self-reported by patient (VAS) |
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E.2.2 | Secondary objectives of the trial |
- 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 10 mg/l and faecal calprotectin value < 250 mg/kg |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the proportion of patients obtaining a reduction of 20% in VAS (compared to baseline) after intervention. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |