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

NCT03574948 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2021-05-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

5-HTP

8 weeks active substance 5-HTP (2 x 100mg per day)

DRUG

Placebo oral capsule

8 weeks placebo (2 x 1 caps per day)

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Martine De Vos, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2021-02-23
Completion
2021-03-03

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574948 on ClinicalTrials.gov