Bifidobacterium breve CCFM1025 Attenuates Major Depression Disorder via Regulating Gut Microbiome and Tryptophan Metabolism: A Randomized Clinical Trial
Abstract
OBJECTIVE
Psychobiotics, as a novel class of probiotics mainly acting on the gut-brain axis, have shown promising prospects in treating psychiatric disorders. Bifidobacterium breve CCFM1025 was validated to have an antidepressant-like effect in mice. This study aims to assess its psychotropic potential in managing major depression disorder (MDD) and unravel the underlying mechanisms.
METHODS
Clinical Trial Registration: https://www.chictr.org.cn/index.aspx (identifier: NO. ChiCTR2100046321). Patients (n=45) diagnosed with MDD were randomly assigned to the Placebo (n=25) and CCFM1025 (n=20) groups. The freeze-dried CCFM1025 in a dose of viable bacteria of 1010 CFU was given to MDD patients daily for four weeks, while the placebo group was given maltodextrin. Changes from baseline in psychometric and gastrointestinal symptoms were evaluated using Hamilton Depression Rating scale-24 Items (HDRS-24), Montgomery-Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS), and Gastrointestinal Symptom Rating Scale (GSRS). Serum measures were also determined, i.e., cortisol, TNF-α, and IL-β. Serotonin turnover in the circulation, gut microbiome composition, and tryptophan metabolites were further investigated for clarifying the probiotics' mechanisms of action.
RESULTS
CCFM1025 showed a better antidepressant-like effect than placebo, based on the HDRS-24 (placebo: M=6.44, SD=5.44; CCFM1025: M=10.40, SD=6.85; t(43)=2.163, P=0.036, d=0.640) and MADRS (placebo:…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 45 participants or records.
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