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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2021-03-03

Brief Summary

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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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Detailed Description

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Conditions

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Crohn Disease Ulcerative Colitis Fatigue Remission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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5-HTP

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

Group Type EXPERIMENTAL

5-HTP

Intervention Type DRUG

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

placebo oral capsule

8 weeks placebo (2 x 1 capsule per day)

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

8 weeks placebo (2 x 1 caps per day)

Interventions

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5-HTP

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

Intervention Type DRUG

Placebo oral capsule

8 weeks placebo (2 x 1 caps per day)

Intervention Type DRUG

Other Intervention Names

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Levotonine placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No