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

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

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

NCT03574948•University Hospital, Ghent

View on ClinicalTrials.gov

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (13)

AZ Imelda

Bonheiden, Belgium

CHU Saint-Pièrre

Brussels, Belgium

UCL Saint-Luc

Brussels, Belgium

ULB Erasme

Brussels, Belgium

UZ Brussel

Brussels, Belgium

Ghent University Hospital

Ghent, Belgium

AZ Maria Middelares

Ghent, Belgium

AZ Sint-Lucas

Ghent, Belgium

UZ Leuven

Leuven, Belgium

CHU Liège

Liège, Belgium

Key Dates

Start Date

December 6, 2018

Primary Completion Date

February 23, 2021

Completion Date

March 3, 2021

Last Updated

May 18, 2021

Enrollment

175

ACTUAL participants

Conditions

Crohn DiseaseUlcerative ColitisFatigueRemission

Interventions

5-HTP

DRUG

Placebo oral capsule

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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