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Crohn DiseasePhase 2TRP-IBDNCT03574948

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

A Phase 2 study testing 5-HTP in people with Crohn Disease and Ulcerative Colitis, run by University Hospital, Ghent at 13 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Crohn Disease, Ulcerative Colitis, Fatigue
What is being tested?
5-HTP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
175 participants
Where
13 sitesBelgium
Study dates
6 Dec 2018to 3 Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Belgium13 sites

  • AZ Imelda

    Bonheiden

  • CHU Saint-Pièrre

    Brussels

  • UCL Saint-Luc

    Brussels

  • ULB Erasme

    Brussels

  • UZ Brussel

    Brussels

  • Ghent University Hospital

    Ghent, 9000

  • AZ Maria Middelares

    Ghent

  • AZ Sint-Lucas

    Ghent

  • UZ Leuven

    Leuven

  • CHU Liège

    Liège

  • CHU Namur

    Namur

  • AZ Damiaan

    Ostend

  • AZ Nikolaas

    Sint-Niklaas

Other trials in Belgium

About this study

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

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.

Being tested
5-HTP, Placebo oral capsule
Medical subject headings
Crohn Disease, Colitis, Ulcerative, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-HTPDrug

    Also called Levotonine

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

  • Placebo oral capsuleDrug

    Also called placebo

    8 weeks placebo (2 x 1 caps per day)

Study groups in NCT03574948
Study groupRoleWhat they receive
5-HTPExperimental8 weeks active substance 5-HTP (2 x 100 mg per day)
Receives: Drug: 5-HTP
placebo oral capsulePlacebo comparator8 weeks placebo (2 x 1 capsule per day)
Receives: Drug: Placebo oral capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: weekly, 16 weeks

Secondary outcomes (8)

  1. 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.

    Measured: week 0, week 8 and week 16

  2. 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.

    Measured: week 0, week 8 and week 16

  3. 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.

    Measured: week 0, week 8 and week 16

  4. Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment

    The possible effect of Levotonine administration on the serum 5-HTP levels will be measured.

    Measured: Week 0, week 8 and week 16

  5. Changes in serum 5-hydroxyindoleacetic acid by treatment

    The possible effect of Levotonine administration on the serum 5-hydroxyindoleacetic levels will be measured.

    Measured: Week 0, week 8 and week 16

  6. Changes in serum serotonin levels by treatment

    The possible effect of Levotonine administration on the serum serotonin levels will be measured.

    Measured: Week 0, week 8 and week 16

  7. Changes in serum melatonin levels by treatment

    The possible effect of Levotonine administration on the serum melatonin levels will be measured.

    Measured: Week 0, week 8 and week 16

  8. 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.

    Measured: Week 0, week 8 and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2018
  2. Study start6 Dec 2018
  3. Primary completion23 Feb 2021
  4. Study completion3 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03574948
Sponsor's protocol ID
2017-005059-10
Other IDs
2017
Acronym
TRP-IBD
Status last verified
Jan 2021
First submitted
22 Jun 2018
Last updated
18 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35940251

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 5-HTP in people with Crohn Disease and Ulcerative Colitis, run by University Hospital, Ghent at 13 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Scale (VAS) after intervention (time frame: weekly, 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03574948, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

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