[en] BACKGROUND & AIMS: Fatigue is highly prevalent among patients with inflammatory bowel disease (IBD), and only limited treatment options are available. Based on the hypothetical link between low serum tryptophan concentrations and fatigue, we determined the effect of 5-hydroxytryptophan supplementation on fatigue in patients with inactive IBD. METHODS: A multicenter randomized controlled trial was performed at 13 Belgian hospitals, including 166 patients with IBD in remission but experiencing fatigue, defined by a fatigue visual analog scale (fVAS) score of ≥5. Patients were treated in a crossover manner with 100 mg oral 5-hydroxytryptophan or placebo twice daily for 2 consecutive periods of 8 weeks. The primary end point was the proportion of patients reaching a ≥20% reduction in fVAS after 8 weeks of intervention. Secondary outcomes included changes in serum tryptophan metabolites, Functional Assessment of Chronic Illness Therapy Fatigue scale, and scores for depression, anxiety, and stress. The effect of the intervention on the outcomes was evaluated by linear mixed modeling. RESULTS: During 5-hydroxytryptophan treatment, a significant increase in serum 5-hydroxytryptophan (estimated mean difference, 52.66 ng/mL; 95% confidence interval [CI], 39.34-65.98 ng/mL; P < .001) and serotonin (3.0 ng/mL; 95 CI, 1.97-4.03 ng/mL; P < .001) levels was observed compared with placebo. The proportion of patients reaching ≥20% reduction in fVAS was similar in placebo- (37.6%) and 5-hydroxytryptophan (35.6%)-treated patients (P = .830). The fVAS reduction (-0.18; 95% CI, -0.81 to 0.46; P = .581) and Functional Assessment of Chronic Illness Therapy Fatigue scale increase (0.68; 95% CI, -2.37 to 3.73; P = .660) were both comparable between 5-hydroxytryptophan and placebo treatment as well as changes in depression, anxiety, and stress scores. CONCLUSIONS: Despite a significant increase in serum 5-hydroxytryptophan and serotonin levels, oral 5-hydroxytryptophan did not modulate IBD-related fatigue better than placebo. (Trial Registration: Belgian Federal Agency for Medication and Health Products, EudraCT number: 2017-005059-10 and ClinicalTrials.gov: NCT03574948, https://clinicaltrials.gov/ct2/show/NCT03574948.).
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Truyens, Marie; Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium,
Lobatón, Triana; Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium,
Ferrante, Marc; Department of Chronic Diseases & Metabolism (CHROMETA), Translational Research
Bossuyt, Peter; Imelda Gastrointestinal (GI) Clinical Research Center, Imelda General Hospital,
Vermeire, Séverine; Department of Chronic Diseases & Metabolism (CHROMETA), Translational Research
Pouillon, Lieven; Imelda Gastrointestinal (GI) Clinical Research Center, Imelda General Hospital,
Dewint, Pieter; Department of Gastroenterology, Algemeen Ziekenhuis (AZ) Maria Middelares, Ghent,
Cremer, Anneline; Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium.
Peeters, Harald; Department of Gastroenterology, Algemeen Ziekenhuis (AZ) St-Lucas, Ghent,
Lambrecht, Guy; Department of Gastroenterology, Algemeen Ziekenhuis (AZ) Damiaan, Ostend,
Louis, Edouard ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Rahier, Jean-François; Department of Gastroenterology, Centre Hospitalier Universitaire (CHU) Université
FWO - Fonds Wetenschappelijk Onderzoek Vlaanderen BIRD - Belgian Inflammatory Bowel Disease Research and Development Group
Funding number :
T000617N
Funding text :
Grant support was received from The Research Foundation–Flanders (FWO) with a fund for applied biomedical research with a primary social finality, No. T000617N, and the Belgian IBD Research and Development
(BIRD) grant.
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