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

NCT03574948 | Completed Phase 2

• 1 other identifier: 2017-005059-10
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 13

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.

Conditions

Crohn Disease; Ulcerative Colitis; Fatigue; Remission

Outcome Measures

Primary Outcomes (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.

  weekly, 16 weeks

Secondary Outcomes (8)

• Changes in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score

  week 0, week 8 and week 16

• Changes in short Depression Anxiety and Stress Scale (DASS21)

  week 0, week 8 and week 16

• Change in Adapted International Physical Activity Questionnaire (IPAQ)

  week 0, week 8 and week 16

• Changes in serum 5-HydroxyTryptophane (5-HTP) by treatment

  Week 0, week 8 and week 16

• Changes in serum 5-hydroxyindoleacetic acid by treatment

  Week 0, week 8 and week 16

Study Arms (2)

5-HTP

EXPERIMENTAL

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

Drug: 5-HTP

placebo oral capsule

PLACEBO COMPARATOR

8 weeks placebo (2 x 1 capsule per day)

Drug: Placebo oral capsule

Interventions

5-HTP DRUG

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

Also known as: Levotonine

5-HTP

Placebo oral capsule DRUG

8 weeks placebo (2 x 1 caps per day)

Also known as: placebo

placebo oral capsule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (13)

AZ Imelda

Bonheiden, Belgium

Location

CHU Saint-Pièrre

Brussels, Belgium

Location

UCL Saint-Luc

Brussels, Belgium

Location

ULB Erasme

Brussels, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

AZ Sint-Lucas

Ghent, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHU Liège

Liège, Belgium

Location

CHU Namur

Namur, Belgium

Location

AZ Damiaan

Ostend, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35940251 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Fatigue

Interventions

5-Hydroxytryptophan

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Martine De Vos, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 2, 2018
• Study Start: December 6, 2018
• Primary Completion: February 23, 2021
• Study Completion: March 3, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (13)