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

Ulcerative Colitis Clinical Trial

— TRP-IBD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574948
• Other study ID #: 2017-005059-10
• Status: Completed
• Phase: Phase 2
• Start date: December 6, 2018
• Est. completion date: March 3, 2021

Study information

• Verified date: January 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: March 3, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Fatigue
• Remission
• Ulcerative Colitis

Intervention

Drug:
• 5-HTP
8 weeks active substance 5-HTP (2 x 100mg per day)
• Placebo oral capsule
8 weeks placebo (2 x 1 caps per day)

Locations

Country	Name	City	State
Belgium	AZ Imelda	Bonheiden
Belgium	CHU Saint-Pièrre	Brussel
Belgium	UCL Saint-Luc	Brussel
Belgium	UZ Brussel	Brussel
Belgium	ULB Erasme	Brussels
Belgium	AZ Maria Middelares	Ghent
Belgium	AZ Sint-Lucas	Ghent
Belgium	Ghent University Hospital	Ghent
Belgium	UZ Leuven	Leuven
Belgium	CHU Liège	Liège
Belgium	CHU Namur	Namur
Belgium	AZ Damiaan	Oostende
Belgium	AZ Nikolaas	Sint-Niklaas

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analog Scale (VAS) after intervention	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.	weekly, 16 weeks
Secondary	Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score	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.	week 0, week 8 and week 16
Secondary	Changes in short Depression Anxiety and Stress Scale (DASS21)	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.	week 0, week 8 and week 16
Secondary	Change in Adapted International Physical Activity Questionnaire (IPAQ)	The adapted IPAQ questionnaire measures the physical activity and will be filled in at week 0, week 8 and week 16.	week 0, week 8 and week 16
Secondary	Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment	The possible effect of Levotonine administration on the serum 5-HTP levels will be measured.	Week 0, week 8 and week 16
Secondary	Changes in serum 5-hydroxyindoleacetic acid by treatment	The possible effect of Levotonine administration on the serum 5-hydroxyindoleacetic levels will be measured.	Week 0, week 8 and week 16
Secondary	Changes in serum serotonin levels by treatment	The possible effect of Levotonine administration on the serum serotonin levels will be measured.	Week 0, week 8 and week 16
Secondary	Changes in serum melatonin levels by treatment	The possible effect of Levotonine administration on the serum melatonin levels will be measured.	Week 0, week 8 and week 16
Secondary	Changes in faecal microbiome/metabolome	since the intestinal bacteria can process tryptophane, changes in the faecal microbiome/metabolome can be possibly caused by the administration of levotonine.	Week 0, week 8 and week 16