# Comparison of defined live biotherapeutic product and fecal microbiota transplantation for treatment of recurrent Clostridioides difficile infection

> **NIH NIH R01** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2024 · $324,480

## Abstract

PROJECT SUMMARY
The treatment of recurrent Clostridioides difficile infection (rCDI) by fecal microbiota transplantation (FMT) is
the defining success amongst therapeutics aimed to manipulate the microbiome with cure rates typically
exceeding 80% of recipients. This success has facilitated numerous clinical trials yielding important insights
that have advanced clinical care including the quantification of the durable stability of frozen fecal slurries that
enabled stool biobanks, the studies of fecal slurry administration that compared efficacies across
administration routes of oral, colonoscopic, and nasogastric, and the application of FMT in other conditions
including ulcerative colitis where it appears to have modest efficacy. However, the use of complex fecal slurries
as a therapy is a challenge due to our inability to completely determine the safety of a product that varies with
each FMT donor, including some that have transmitted opportunistic pathogens that led to serious adverse
events. The scaling of FMT is also a challenge, as the drug material is sourced from individual human
donations that are finite in supply and labor intensive to process into the final product. We propose to
administer live biotherapeutic products (LBP) as an alternative to FMT. We have isolated the strains for this
LBP from known-successful FMT donors allowing us to compare (Aim 1) the clinical response and (Aim 2) the
microbial engraftment of the FMT with that of the LBP. The LBP was specifically designed to contain prevalent
human gut microbes that have engrafted in a majority of recipients and that are not associated with severe
adverse events in prior FMT studies. The results from this pilot and feasibility clinical trial (60 subjects, N=30
FMT and N=30 LBP) will provide important safety data, clinical insights, and basic science results to advance
the potential of LBPs as novel therapeutics.

## Key facts

- **NIH application ID:** 10845658
- **Project number:** 5R01DK130337-03
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Jeremiah James Faith
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $324,480
- **Award type:** 5
- **Project period:** 2022-09-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10845658

## Citation

> US National Institutes of Health, RePORTER application 10845658, Comparison of defined live biotherapeutic product and fecal microbiota transplantation for treatment of recurrent Clostridioides difficile infection (5R01DK130337-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10845658. Licensed CC0.

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