The American journal of gastroenterology · 2026
Microbiome-Directed Therapy for Fatigue in Quiescent Inflammatory Bowel Disease: A Randomized Placebo-Controlled Trial of Multistrain Probiotic Supplementation.
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Borren Nienke Z, Paulides Emma, Klaassen Marjolein A Y, Alm Eric, Xavier Ramnik J, van der Woude C Janneke, Ananthakrishnan Ashwin N
Аннотация
INTRODUCTION: Fatigue is a challenging symptom for patients with inflammatory bowel diseases (IBD). Emerging evidence links alterations in the gut microbiome with fatigue in IBD, highlighting the potential of microbiome-targeted treatments. Our aim was to evaluate the clinical efficacy and biological effects of a multistrain probiotic supplementation on fatigue in patients with quiescent IBD.
METHODS: This multicenter, placebo-controlled, randomized controlled trial included patients with quiescent IBD, defined as being in clinical remission and a colonoscopy within 1 year which demonstrated no active disease, and with significant fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score ≤43). Patients were randomized to receive either probiotics (Ecologic BARRIER, containing 9 different bacterial strains) or placebo for 12 weeks. Gut microbiome and serum metabolome were analyzed at baseline and at the end of the study.
RESULTS: Our study enrolled 100 patients (52 Crohn's disease, 44 ulcerative colitis, 4 IBD-unspecified) with quiescent IBD and with a mean age of 41 years; 61% were women. After 12 weeks, 29.4% of the probiotic group and 40.0% of the placebo group met criteria for no fatigue ( P = 0.34). However, all participants reported an improvement in fatigue ( P < 0.001) with the most striking change noted at 4 weeks in both groups. Probiotic treatment led to beneficial shifts in gut microbiome and serum metabolome composition, particularly an increase in Bifidobacterium animalis after 12 weeks.
DISCUSSION: Although 12 weeks of probiotic administration was not associated with relief of fatigue in patients with quiescent IBD, we observed beneficial alterations in the gut microbiome and serum metabolome.
METHODS: This multicenter, placebo-controlled, randomized controlled trial included patients with quiescent IBD, defined as being in clinical remission and a colonoscopy within 1 year which demonstrated no active disease, and with significant fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue score ≤43). Patients were randomized to receive either probiotics (Ecologic BARRIER, containing 9 different bacterial strains) or placebo for 12 weeks. Gut microbiome and serum metabolome were analyzed at baseline and at the end of the study.
RESULTS: Our study enrolled 100 patients (52 Crohn's disease, 44 ulcerative colitis, 4 IBD-unspecified) with quiescent IBD and with a mean age of 41 years; 61% were women. After 12 weeks, 29.4% of the probiotic group and 40.0% of the placebo group met criteria for no fatigue ( P = 0.34). However, all participants reported an improvement in fatigue ( P < 0.001) with the most striking change noted at 4 weeks in both groups. Probiotic treatment led to beneficial shifts in gut microbiome and serum metabolome composition, particularly an increase in Bifidobacterium animalis after 12 weeks.
DISCUSSION: Although 12 weeks of probiotic administration was not associated with relief of fatigue in patients with quiescent IBD, we observed beneficial alterations in the gut microbiome and serum metabolome.