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

May 17, 2021 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • AZ Imelda
      • Brussel, Belgium
        • UZ Brussel
      • Brussel, Belgium
        • CHU Saint-Pierre
      • Brussel, Belgium
        • UCL Saint-Luc
      • Brussels, Belgium
        • ULB Erasme
      • Ghent, Belgium, 9000
        • Ghent University Hospital
      • Ghent, Belgium
        • AZ Maria Middelares
      • Ghent, Belgium
        • AZ Sint-Lucas
      • Leuven, Belgium
        • UZ Leuven
      • Liège, Belgium
        • CHU Liege
      • Namur, Belgium
        • CHU Namur
      • Oostende, Belgium
        • AZ Damiaan
      • Sint-Niklaas, Belgium
        • AZ Nikolaas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5-HTP
8 weeks active substance 5-HTP (2 x 100 mg per day)
Drug: 5-HTP
8 weeks active substance 5-HTP (2 x 100mg per day)
Other Names:
  • Levotonine
Placebo Comparator: placebo oral capsule
8 weeks placebo (2 x 1 capsule per day)
Drug: Placebo oral capsule
8 weeks placebo (2 x 1 caps per day)
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale (VAS) after intervention
Time Frame: weekly, 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
Time Frame: week 0, week 8 and week 16
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
Changes in short Depression Anxiety and Stress Scale (DASS21)
Time Frame: week 0, week 8 and week 16
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
Change in Adapted International Physical Activity Questionnaire (IPAQ)
Time Frame: week 0, week 8 and week 16
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
Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment
Time Frame: Week 0, week 8 and week 16
The possible effect of Levotonine administration on the serum 5-HTP levels will be measured.
Week 0, week 8 and week 16
Changes in serum 5-hydroxyindoleacetic acid by treatment
Time Frame: Week 0, week 8 and week 16
The possible effect of Levotonine administration on the serum 5-hydroxyindoleacetic levels will be measured.
Week 0, week 8 and week 16
Changes in serum serotonin levels by treatment
Time Frame: Week 0, week 8 and week 16
The possible effect of Levotonine administration on the serum serotonin levels will be measured.
Week 0, week 8 and week 16
Changes in serum melatonin levels by treatment
Time Frame: Week 0, week 8 and week 16
The possible effect of Levotonine administration on the serum melatonin levels will be measured.
Week 0, week 8 and week 16
Changes in faecal microbiome/metabolome
Time Frame: Week 0, week 8 and week 16
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Martine De Vos, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2018

Primary Completion (Actual)

February 23, 2021

Study Completion (Actual)

March 3, 2021

Study Registration Dates

First Submitted

June 22, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-005059-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fatigue

Clinical Trials on 5-HTP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe