Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-HTP | Experimental | 8 weeks active substance 5-HTP (2 x 100 mg per day) |
|
| placebo oral capsule | Placebo Comparator | 8 weeks placebo (2 x 1 capsule per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-HTP | Drug | 8 weeks active substance 5-HTP (2 x 100mg per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 0, week 8 and week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martine De Vos, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Imelda | Bonheiden | Belgium | ||||
| CHU Saint-Pièrre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35940251 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo oral capsule | Drug | 8 weeks placebo (2 x 1 caps per day) |
|
|
| 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. | week 0, week 8 and week 16 |
| 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. | 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. | Week 0, week 8 and week 16 |
| Changes in serum 5-hydroxyindoleacetic acid by treatment | The possible effect of Levotonine administration on the serum 5-hydroxyindoleacetic levels will be measured. | Week 0, week 8 and week 16 |
| Changes in serum serotonin levels by treatment | The possible effect of Levotonine administration on the serum serotonin levels will be measured. | Week 0, week 8 and week 16 |
| Changes in serum melatonin levels by treatment | The possible effect of Levotonine administration on the serum melatonin levels will be measured. | Week 0, week 8 and week 16 |
| 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. | Week 0, week 8 and week 16 |
| Brussels |
| Belgium |
| UCL Saint-Luc | Brussels | Belgium |
| ULB Erasme | Brussels | Belgium |
| UZ Brussel | Brussels | Belgium |
| Ghent University Hospital | Ghent | 9000 | Belgium |
| AZ Maria Middelares | Ghent | Belgium |
| AZ Sint-Lucas | Ghent | Belgium |
| UZ Leuven | Leuven | Belgium |
| CHU Liège | Liège | Belgium |
| CHU Namur | Namur | Belgium |
| AZ Damiaan | Ostend | Belgium |
| AZ Nikolaas | Sint-Niklaas | Belgium |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006916 | 5-Hydroxytryptophan |
| ID | Term |
|---|---|
| D014364 | Tryptophan |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided