The impact of Bifidobacterium breve BBr60 (BBr60) on metabolic and gastrointestinal health in healthy adults: A combined in vitro metabolomic and randomized, double-blind, placebo-controlled study.

2025-08
Clinical nutrition (Edinburgh, Scotland) 51

PubMed: 40652782
DOI: 10.1016/j.clnu.2025.07.004

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 109 healthy adults aged 19-45
Methods: 8-week double-blind, randomized, placebo-controlled study; participants were randomly assigned to receive either a BBr60 supplement (10^10 CFU/day) or a placebo (maltodextrin)

Purpose

This study aims to evaluate the physiological and psychological health impacts of Bifidobacterium breve BBr60 (BBr60) on healthy adults.

Methods

The study was divided into preclinical research and a clinical trial phase. In the preclinical study, the bioactive components of BBr60 were analyzed through LC-MS targeted metabolomics. In the clinical trial, 109 healthy adults aged 19-45 were recruited to participate in an 8-week double-blind, randomized, placebo-controlled study. Participants were randomly assigned to receive either a BBr60 supplement (10¹⁰ CFU/day) or a placebo (maltodextrin). Throughout the study, liver function, metabolic markers, cardiovascular and body composition metrics were assessed. Volunteer scores on the Alcohol Dependence Scale (ADS), Nepean Dyspepsia Index (NDI), Gastrointestinal Symptom Scale (GIS), and Positive and Negative Affect Schedule (PANAS) were recorded, and the impact on the intestinal microbiota structure and function of healthy participants was analyzed through 16S rRNA sequencing.

Results

The preclinical study indicated the role of BBr60 in modulating key metabolic pathways, including those involved in ABC transporters, arginine, proline, and tryptophan metabolism. Clinical trial results demonstrated significant improvements in high-density lipoprotein (HDL) levels and reductions in total cholesterol with BBr60 supplementation. Gastrointestinal symptoms and emotional states also improved, with significant reductions in ADS scores (p = 0.000), particularly in symptoms related to alcohol consumption such as post-drinking memory loss and tremulous delirium. Additionally, significant enhancements in gastrointestinal health were observed, as indicated by a notable decrease in NDI scores (p = 0.002), suggesting reduced impact of stomach issues on daily life. GIS scores further confirmed improvements in gastrointestinal function, particularly in early satiety and appetite. While overall emotional changes were not significant, positive emotional scores increased post-intervention, and negative emotional scores decreased. The probiotic demonstrated good safety and tolerability throughout the 8-week trial period.

Conclusion

Supplementation with BBr60 not only significantly alleviated neuropsychiatric symptoms associated with alcohol consumption but also showed potential benefits in enhancing gastrointestinal and metabolic health. These findings support further research into BBr60 as a potential non-pharmacological intervention to improve both psychological and physiological health.

Trial registration number

NCT06196892 (ClinicalTrials.gov).

Research Insights

Bifidobacterium breve BBr60→Improved Alcohol-Related Neuropsychiatric Symptoms
Supplementation with BBr60 not only significantly alleviated neuropsychiatric symptoms associated with alcohol consumption... with significant reductions in ADS scores (p = 0.000), particularly in symptoms related to alcohol consumption such as post-drinking memory loss and tremulous delirium.
Effect
Beneficial
Effect size
Moderate
Bifidobacterium breve BBr60→Improved Blood Lipid Profile
Clinical trial results demonstrated significant improvements in high-density lipoprotein (HDL) levels and reductions in total cholesterol with BBr60 supplementation.
Effect
Beneficial
Effect size
Moderate
Bifidobacterium breve BBr60→Improved Emotional State
While overall emotional changes were not significant, positive emotional scores increased post-intervention, and negative emotional scores decreased.
Effect
Beneficial
Effect size
Small
Bifidobacterium breve BBr60→Improved Gastrointestinal Symptoms
Gastrointestinal symptoms and emotional states also improved, with significant reductions in ADS scores... Additionally, significant enhancements in gastrointestinal health were observed, as indicated by a notable decrease in NDI scores... GIS scores further confirmed improvements in gastrointestinal function, particularly in early satiety and appetite.
Effect
Beneficial
Effect size
Moderate