Primary endpoint of 5-hydroxytryptophan for fatigue in IBD not met

5-hydroxytryptophan was not superior to placebo in reducing fatigue among participants with quiescent inflammatory bowel disease (IBD) in the phase 2 Trp-IBD trial. However, a reduction in fatigue was reported in both treatment groups, suggesting that supporting therapies and attention for fatigue may have improved symptoms in these patients.

Fatigue is common among patients with IBD, with 72% of the patients with active disease and 47% of the patients in remission reporting this symptom, explained Dr Marie Truyens (Ghent University Hospital, Belgium) [1]. Since tryptophan has been associated with fatigue in IBD, a multicentre, double-blind, cross-over, randomised-controlled trial (NCT03574948) was conducted to assess the efficacy of 5-hydroxytryptophan supplementation in fatigued patients with inactive IBD. The participants were randomised to 5- hydroxytryptophan first, 100 mg twice daily (n=82), or placebo first (n=84) for 8 weeks. Subsequently, the participants switched treatment groups. The primary endpoint was the proportion of participants with ≥20% reduction on the Visual Analogue Scale for Fatigue (fatigue-VAS).

After 16 weeks, approximately 35% of the 166 participants in either treatment group showed a ≥20% reduction on the fatigue-VAS. Since no significant difference was reported between the treatment groups (P=0.830), the primary endpoint was not met. In addition, similar reductions in depression, anxiety, and stress were reported for participants receiving placebo and participants receiving 5-hydroxytryptophan. Next, increases in 5-hydroxytryptophan and serotonin levels were observed, but these were not related to a reduction in fatigue.

Dr Truyens argued that the reduction in fatigue that was observed among placebo receivers may be associated with the extra attention that was given to this symptom. “Fatigue is often overlooked in patients with IBD. Additional clinical support and increased patient awareness may have resulted in a reduction in fatigue in this study population.”

1. Truyens M, et al. A randomized placebo controlled clinical trial with 5-hydroxytryptophan in patients with quiescent Inflammatory Bowel Disease and fatigue (Trp-IBD). OP28, ECCO 2022, 16–19 February.

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Posted on 12 April 20228 April 2024