What is the Origin of Live Biotherapeutic Products?

This is a formal regulatory term coined by agencies like the FDA to categorize products that differ fundamentally from traditional probiotics due to their therapeutic intent and rigorous manufacturing standards. The concept stems from the scientific recognition of the microbiome's profound role in human health and disease.

What is the Mechanism of Live Biotherapeutic Products?

These products exert their therapeutic effect by colonizing the gastrointestinal tract or other mucosal surfaces, where they produce beneficial metabolites like short-chain fatty acids, modulate the host's immune system, or directly interact with the enteric nervous system. This action can profoundly influence systemic inflammation, nutrient absorption, and the gut-hormone axis, offering targeted support for overall health.

Live Biotherapeutic Products ∞ Area

Live Biotherapeutic Products

Meaning

Live Biotherapeutic Products (LBPs) are a class of biological products that contain live microorganisms, such as specific strains of bacteria or yeast, which are administered to a patient with the explicit intention to prevent, treat, or cure a disease. Unlike conventional dietary supplements, LBPs are subject to rigorous regulatory pathways due to their clinical claims and defined biological mechanism. They represent a new frontier in microbiome-based medicine.