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Drug intelligence / Profile preview
Bifidobacterium breve BR03 + Bifidobacterium breve B632
- Development stage
- Phase 4
- Lead developer
- Probiotical
- Modality
- Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics
- Administration
- Oral
01
Overview
Bifidobacterium breve BR03 + Bifidobacterium breve B632 is a probiotic combination consisting of two specific bacterial strains designed for the prevention and management of infant colic. Marketed under the brand name BIFIBABY®, these strains were selected for their ability to inhibit the growth of gas-producing coliforms and Enterobacteriaceae, which are often found in higher concentrations in the gut of colicky infants. The product aims to restore a healthy gut microbiota balance and increase beneficial Bifidobacteria populations, thereby reducing intestinal inflammation and gas production. Clinical evaluation in the Phase 4 NEOBIFI study demonstrated that while the overall reduction in crying time was not significantly different from placebo across the entire cohort, a significant benefit was observed in the sub-group of formula-fed infants.
- Brand names
- BIFIBABY
- Other names
- Bifidobacterium breve B632 and BR03NEOBIFI probioticBifidobacterium breve BR03 + Bifidobacterium breve B632
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