Creating defined live microbial treatments for infections and inflammation

Manufacture of defined live microbial therapeutics for infectious and inflammatory disease

NIH-funded research Icahn School of Medicine at Mount Sinai · NIH-11024873

This study is testing a new treatment made from specially grown bacteria to help people with recurring Clostridioides difficile infections, aiming to see if it's more effective and safer than traditional stool transplants.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionIcahn School of Medicine at Mount Sinai NIH-funded
Lab location1 site (New York, United States)
Project IDNIH-11024873 on NIH RePORTER

What this research studies

This research focuses on developing defined live biotherapeutic products (LBPs) to treat recurrent Clostridioides difficile infections. Unlike traditional fecal-based therapies, which can vary in safety and require stool donations, this approach uses in vitro manufactured bacterial strains that can be produced at scale. The study aims to compare the effectiveness of these defined LBPs against fecal transplants in a clinical trial, providing a more consistent and safer treatment option for patients. By utilizing specific bacterial strains known for their therapeutic benefits, the research seeks to enhance patient outcomes in managing infections.

Who could benefit from this research

Good fit: Ideal candidates for this research are patients experiencing recurrent Clostridioides difficile infections who have not responded to standard treatments.

Not a fit: Patients with non-infectious gastrointestinal disorders or those not affected by Clostridioides difficile infections may not benefit from this research.

Why it matters

Potential benefit: If successful, this research could provide a safer and more effective treatment option for patients suffering from recurrent Clostridioides difficile infections.

How similar studies have performed: Previous research has shown promise in using defined microbial therapeutics, indicating a potential for success with this novel approach.

Where this research is happening

New York, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.