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Completed

NCT Number: NCT03574948

5-HTP in Patients With IBD 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.

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Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Fatigue Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Remission Signs and Symptoms Ulcerative Colitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AZ Imelda, Bonheiden, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-HTP

Drug

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

Other names: Levotonine

Placebo oral capsule

Drug

8 weeks placebo (2 x 1 caps per day)

Other names: placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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

Acronym: TRP-IBD

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2018
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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