Clinical trial NCT03574948: 5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores
Official title: Multicentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue Scores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Ulcerative Colitis
Fatigue
Remission
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2018-07-02
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) after intervention
timeFrame: weekly, 16 weeks
Secondary outcomes:
measure: Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
timeFrame: week 0, week 8 and week 16
measure: Changes in short Depression Anxiety and Stress Scale (DASS21)
timeFrame: week 0, week 8 and week 16
measure: Change in Adapted International Physical Activity Questionnaire (IPAQ)
timeFrame: week 0, week 8 and week 16
measure: Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment
timeFrame: Week 0, week 8 and week 16
measure: Changes in serum 5-hydroxyindoleacetic acid by treatment
timeFrame: Week 0, week 8 and week 16
measure: Changes in serum serotonin levels by treatment
timeFrame: Week 0, week 8 and week 16
measure: Changes in serum melatonin levels by treatment
timeFrame: Week 0, week 8 and week 16
measure: Changes in faecal microbiome/metabolome
timeFrame: Week 0, week 8 and week 16
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: AZ Imelda
city: Brussels
country: Belgium
facility: ULB Erasme
city: Brussel
country: Belgium
facility: CHU Saint-Pièrre
city: Brussel
country: Belgium
facility: UCL Saint-Luc
city: Brussel
country: Belgium
facility: UZ Brussel
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Ghent
country: Belgium
facility: AZ Maria Middelares
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU Liège
city: Namur
country: Belgium
facility: CHU Namur
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
Study officials:
affiliation: University Hospital, Ghent
name: Martine De Vos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Truyens M, Lobaton T, Ferrante M, Bossuyt P, Vermeire S, Pouillon L, Dewint P, Cremer A, Peeters H, Lambrecht G, Louis E, Rahier JF, Dewit O, Muls V, Holvoet T, Vandermeulen L, Peeters A, Gonzales GB, Bos S, Laukens D, De Vos M. Effect of 5-Hydroxytryptophan on Fatigue in Quiescent Inflammatory Bowel Disease: A Randomized Controlled Trial. Gastroenterology. 2022 Nov;163(5):1294-1305.e3. doi: 10.1053/j.gastro.2022.07.052. Epub 2022 Aug 6.