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

Primary Purpose

Crohn Disease, Ulcerative Colitis, Fatigue

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
5-HTP
Placebo oral capsule
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • AZ Imelda
  • ULB Erasme
  • CHU Saint-Pièrre
  • UCL Saint-Luc
  • UZ Brussel
  • Ghent University Hospital
  • AZ Maria Middelares
  • AZ Sint-Lucas
  • UZ Leuven
  • CHU Liège
  • CHU Namur
  • AZ Damiaan
  • AZ Nikolaas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

5-HTP

placebo oral capsule

Arm Description

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

8 weeks placebo (2 x 1 capsule per day)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment
The possible effect of Levotonine administration on the serum 5-HTP levels will be measured.
Changes in serum 5-hydroxyindoleacetic acid by treatment
The possible effect of Levotonine administration on the serum 5-hydroxyindoleacetic levels will be measured.
Changes in serum serotonin levels by treatment
The possible effect of Levotonine administration on the serum serotonin levels will be measured.
Changes in serum melatonin levels by treatment
The possible effect of Levotonine administration on the serum melatonin levels will be measured.
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.

Full Information

First Posted
June 22, 2018
Last Updated
May 17, 2021
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT03574948
Brief Title
5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
March 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Ulcerative Colitis, Fatigue, Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-HTP
Arm Type
Experimental
Arm Description
8 weeks active substance 5-HTP (2 x 100 mg per day)
Arm Title
placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
8 weeks placebo (2 x 1 capsule per day)
Intervention Type
Drug
Intervention Name(s)
5-HTP
Other Intervention Name(s)
Levotonine
Intervention Description
8 weeks active substance 5-HTP (2 x 100mg per day)
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
placebo
Intervention Description
8 weeks placebo (2 x 1 caps per day)
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) after intervention
Description
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.
Time Frame
weekly, 16 weeks
Secondary Outcome Measure Information:
Title
Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
Description
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.
Time Frame
week 0, week 8 and week 16
Title
Changes in short Depression Anxiety and Stress Scale (DASS21)
Description
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.
Time Frame
week 0, week 8 and week 16
Title
Change in Adapted International Physical Activity Questionnaire (IPAQ)
Description
The adapted IPAQ questionnaire measures the physical activity and will be filled in at week 0, week 8 and week 16.
Time Frame
week 0, week 8 and week 16
Title
Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment
Description
The possible effect of Levotonine administration on the serum 5-HTP levels will be measured.
Time Frame
Week 0, week 8 and week 16
Title
Changes in serum 5-hydroxyindoleacetic acid by treatment
Description
The possible effect of Levotonine administration on the serum 5-hydroxyindoleacetic levels will be measured.
Time Frame
Week 0, week 8 and week 16
Title
Changes in serum serotonin levels by treatment
Description
The possible effect of Levotonine administration on the serum serotonin levels will be measured.
Time Frame
Week 0, week 8 and week 16
Title
Changes in serum melatonin levels by treatment
Description
The possible effect of Levotonine administration on the serum melatonin levels will be measured.
Time Frame
Week 0, week 8 and week 16
Title
Changes in faecal microbiome/metabolome
Description
since the intestinal bacteria can process tryptophane, changes in the faecal microbiome/metabolome can be possibly caused by the administration of levotonine.
Time Frame
Week 0, week 8 and week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine De Vos, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Imelda
City
Bonheiden
Country
Belgium
Facility Name
ULB Erasme
City
Brussels
Country
Belgium
Facility Name
CHU Saint-Pièrre
City
Brussel
Country
Belgium
Facility Name
UCL Saint-Luc
City
Brussel
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Maria Middelares
City
Ghent
Country
Belgium
Facility Name
AZ Sint-Lucas
City
Ghent
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
CHU Liège
City
Liège
Country
Belgium
Facility Name
CHU Namur
City
Namur
Country
Belgium
Facility Name
AZ Damiaan
City
Oostende
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint-Niklaas
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35940251
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.
Results Reference
derived

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

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