# Fecal Microbiota Transplant for C. difficile Infection in Solid Organ Transplant Recipients

> **NIH NIH U01** · UNIVERSITY OF WISCONSIN-MADISON · 2021 · $1,005,421

## Abstract

Abstract
Clostridium difficile is the most frequent bacterial cause of antibiotic-associated diarrhea. Solid
organ transplant recipients have a higher rate of C. difficile infection (CDI), and greater risk for
adverse consequences because of immunosuppression, frequent antibiotic use and medical
procedures all of which disrupt the normal gut microbiota. Dysbiosis of the gut microbiota
predisposes to CDI which, despite treatment can recur in 30% of patients. A novel way to
prevent CDI recurrence is by instilling feces from a healthy individual into the intestine of the
CDI patient, thereby restoring balance in the gut microbiota. However, it is unknown whether or
not fecal microbiota transplantation (FMT) is an efficacious choice for CDI recurrence prevention
in SOT recipients. We propose a randomized, double-blind double-dummy placebo-controlled
trial at five sites comparing FMT with oral vancomycin for 158 SOT recipients with at least a first
but no more than 3 recurrences of CDI. We will collect fecal and blood samples from subjects
prior to and after FMT and collect data on recurrence, CDI-related quality of life, microbiota
composition and function. The trial's primary endpoint is recurrent CDI in the 60-day time frame
following completion of treatment. Secondary outcomes are safety and gut microbiota
characteristics. Each subject will contribute 6 stool samples, 3 blood samples and will have 6
clinic visits. Total duration of follow-up will be 24 weeks per subject. The FMT will be
administered via enema using frozen stool from universal donors. By following patients for 6
months, we will determine whether FMT successfully and safely reduces recurrence of CDI and
improves other outcomes in SOT recipients with CDI.

## Key facts

- **NIH application ID:** 10241381
- **Project number:** 5U01AI125053-04
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** NASIA SAFDAR
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,005,421
- **Award type:** 5
- **Project period:** 2018-09-15 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10241381

## Citation

> US National Institutes of Health, RePORTER application 10241381, Fecal Microbiota Transplant for C. difficile Infection in Solid Organ Transplant Recipients (5U01AI125053-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10241381. Licensed CC0.

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