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Researchers at ÌìÃÀ´«Ã½ have launched a clinical trial investigating whether a microbiome-based therapy can help prevent preterm birth in women at high risk of early labour.

This trial represents a truly unique opportunity to test an intervention that targets a clearly defined cause of PTB, rather than a one size fits all solution." Dr Lynne Sykes FLIP 2 Chief Investigator and Clinical Associate Professor in Obstetrics, Department of Metabolism, Digestion and Reproduction

The Phase 2b FLIP 2 trial, led by researchers at Imperial’s Department of Metabolism, Digestion and Reproduction, will evaluate the safety and effectiveness of LACTIN-V, a live biotherapeutic designed to restore healthy vaginal bacteria linked to lower rates of preterm birth.

Preterm birth (PTB) is the leading cause of death in children under five worldwide and is associated with long-term health complications for surviving babies. Despite its global impact, treatment options to prevent preterm birth remain limited.

The researchers, based at Imperial's March of Dimes Prematurity Research Centre and the , hope the trial could lead to a more targeted and personalised approach to preventing premature birth by addressing disruption of the vaginal microbiome, an increasingly recognised risk factor for pregnancy complications including preterm birth and late miscarriage.

, FLIP 2 Chief Investigator and Associate Professor in Obstetrics at ÌìÃÀ´«Ã½ and Honorary Consultant Obstetrician at Imperial College Healthcare NHS Trust said: "For families facing the fear of preterm birth, the absence of effective treatments for microbiome imbalance in the reproductive tract is devastating. This trial represents a truly unique opportunity to test an intervention that targets a clearly defined cause of PTB, rather than a one‑size‑fits‑all solution. If successful, it could move us toward a far more personalised and precise approach to preventing preterm birth, giving women a better chance to deliver their babies safely at the right time."

LACTIN-V contains Lactobacillus crispatus, a naturally occurring bacterium associated with a healthy vaginal microbiome. The treatment is designed to restore stable levels of protective bacteria and reduce inflammation linked to early labour.

Previous research conducted at Imperial through the found the treatment was safe, well tolerated and acceptable to pregnant women at high risk of preterm birth. Researchers also observed lower rates of preterm birth compared with historical controls, supporting progression to the larger placebo-controlled Phase 2b study. FLIP 2’s double-blind trial will recruit 360 pregnant women at high risk of preterm birth across four maternity units in the UK.

, Professor of Obstetrics and Gynaecology and Acting Head of Imperial’s Department of Metabolism, Digestion and Reproduction, said: "This exciting trial represents a paradigm change in the prevention of PTB, targeting activation of host immune responses to the reproductive tract microbiome. It is the first new treatment for preterm birth in decades, and unlike previous therapies, aims to prevent the activation of the mechanisms causing preterm labor, rather than trying to stop preterm labour once it has started."

Preterm birth affects an estimated 13 million babies globally each year and remains a major cause of infant mortality and long-term disability. Researchers hope advances in understanding the vaginal microbiome could open new avenues for prevention and treatment.

The study is being led by Dr Lynne Sykes, alongside Professor Phillip Bennett and Dr Ryan Love, all from Imperial’s Department of Metabolism, Digestion and Reproduction, The trial is being conducted in partnership with ., the developer of LACTIN-V, and supported by , the Imperial Clinical Trials Unit, the and .