P0648 The Safety and Effects of a Dual-Strain Probiotic Versus Placebo on Fatigue in Patients with Ulcerative Colitis
Authors: Carroll A , Walker C , Magdeldin H , Breslin N , O’Donnell S , Ryan B , McNamara D , Corr S , O’Connor A ,   Tallaght University Hospital
Published: January 2025

Abstract

Background
Ulcerative colitis (UC) is a form of inflammatory bowel disease (IBD) characterised by chronic mucosal inflammation of the colon. Patients with IBD may have higher fatigue scores compared to non-IBD controls [1] with up to 41% reporting fatigue as a debilitating symptom [2]. Previous clinical trials have demonstrated anti-inflammatory properties of Bifidobacterium longum 35624® in people with UC [3], and increased energy/vitality with Bifidobacterium longum 1714® in a healthy population [4]. However, studies of this dual combination of strains have not been conducted in people with IBD.

Methods
This single-centre, randomised, double-blind, placebo-controlled trial investigated the safety, tolerance and effect on fatigue of 12-weeks’ intervention with a dual-strain probiotic containing B. longum strains 35624 and 1714 (probiotic) versus an identical placebo. Fatigue (IBD Fatigue Self-Assessment Scale Section II; IBD-F-II), fecal calprotectin and plasma C-reactive protein (CRP) values were measured at baseline and 12 weeks. Safety and tolerance were measured with by monitoring of adverse events throughout the study period.

Results
59 participants completed the study (probiotic n=30; placebo n=29)(Table 1). There was a statistically significant reduction in IBD-F-II scores at 12 weeks compared to baseline in both the probiotic (p=0.0003) and placebo (p&lt;0.0001) groups, with no significant difference between groups (p=0.398)(Table 2). There were no significant changes in calprotectin or CRP from baseline to week 12 in the probiotic (p=0.80 and p=0.27) or placebo (p=0.76 and p=0.47) groups. No adverse events were thought to be related to the intervention.

Conclusion
The findings of this study showed statistically significant improvements in fatigue scores in individuals with UC following 12 weeks of probiotic and placebo intervention respectively, which may be suggestive of a high placebo response in the UC population. Contrary to previous clinical findings showing improvements to plasma CRP with B. longum 35624 in people with UC [3], significant changes in inflammatory markers were not observed in the present study. This study also provides evidence to show that a combination of B. longum 35624 and 1714 was safe and well-tolerated by UC patients. Additional analysis investigating the effect of the probiotic intervention on the gut microbiome is warranted. Further studies conducted in a larger sample are required to better understand the placebo response in the UC population.

References
1.Gibble TH, Minyang S, Xhou X, Naegeli AN, Dubey S, Lewis JD. Association of Fatigue with disease activity and clinical manifestations in patients with Crohn’s Disease and Ulcerative Colitis: An Observational Cross-Sectional Study in the United States. Current Medical Research and Opinion. 2024;9:1537-1544.
2.Römkens TEH, van Vugt-van Pinxteren MWJ, Nagengast FM, van Oijen MGH, de Jong DJ. High prevalence of fatigue in inflammatory bowel disease: A case control study. Journal of Crohn’s and Colitis. 2011;5(4):332-7.
3.Groeger D, O’Mahony L, Murphy EF, Bourke JF, Dinan T, Kiely B, Shanahan F, Quigley EM. Bifidobacterium infantis 35624 modulates host inflammatory processes beyond the gut. Gut Microbes. 2013;4(4):325-339.
4.Wang H, Braun C, Murphy EM, Enck P. Bifidobacterium longum 1714™ Strain Modules Brain Activity of Healthy Volunteers During Social Stress. American Journal of Gastroenterology. 2019;144(7):1152-1162.