INTESTIFIX 001

**INTESTIFIX 001** is an investigational, encapsulated fecal microbiota transfer (FMT) product designed for oral administration to restore intestinal microbiome diversity and function. Developed and manufactured by the **Cologne Microbiota Bank (CMB)** at the **University of Cologne**, it consists of a diverse consortium of healthy gut bacteria processed from donor stool under Good Manufacturing Practice (GMP) conditions. The primary mechanism of action involves the restoration of microbial homeostasis, which competitively inhibits the colonization of multidrug-resistant pathogens, improves intestinal barrier integrity, and modulates systemic immune responses. In oncology, INTESTIFIX 001 is being evaluated for its ability to enhance anti-tumor immunity—specifically by increasing CD8+ T cell infiltration—in patients with advanced hepatocellular carcinoma who are resistant to immune checkpoint inhibitors. It is currently undergoing Phase II clinical trials for several indications, including the maintenance of remission in Crohn's disease and the eradication of multidrug-resistant Enterobacteriaceae.

Other names

Intestifixencapsulated fecal microbiota transferFecal microbiota transfer capsulesFMT Capsules