Malnutrition: The first participants have been enrolled in the Optimilk F-60 study

A treatment for the most vulnerable children

F-60 is intended for children suffering from acute malnutrition with medical complications who require hospitalization. Upon admission, their vital functions are often severely impaired.

The Optimilk F-60 project was designed to support this initial stabilization phase and better address the physiological needs of these children. Initiated by nutrition specialists at MSF and researchers from icddr,b—a world-leading centre for clinical research on child malnutrition—the project aims to rethink the current treatment by incorporating the latest scientific evidence.

A clinical trial grounded in field realities

The ongoing study, conducted by icddr,b, is a Phase 1 clinical trial whose primary objective is to assess the safety and tolerability of F-60 by studying how this new formula is absorbed and metabolized by the body, before considering larger-scale efficacy studies.

A total of 320 hospitalized children will be enrolled. They represent a wide range of clinical profiles, from relatively stable cases to more critical conditions, reflecting the patients treated in MSF-supported settings. This approach will allow F-60 to be evaluated under conditions that closely mirror real-world hospital practice.

The F-60 formula combines whole milk powder, vitamin and mineral premixes, and amino acids. Its ingredients are sourced through certified supply chains that comply with United Nations standards and Codex Alimentarius recommendations for foods for special medical purposes.

The trial aims to confirm that this formulation, based on well-established ingredients, can be safely administered to critically ill children.

A long-term investment for lasting impact

Developing a treatment for children hospitalized with acute malnutrition requires both scientific rigor and ethical caution. This Phase 1 study, expected to last 12 to 15 months, represents the first step in a long-term research programme that may be followed by additional field studies and a regulatory pathway essential for future large-scale implementation.

It is a long process, commensurate with the scale and importance of the challenge.

While modest in appearance, this innovation could have a major impact. Its ambition is clear: to improve a globally used standard treatment and, ultimately, enhance the care of thousands of malnourished children, far beyond MSF programmes alone. des seuls programmes de MSF.