# Redefining C.difficile patient outcomes through network medicine

> **NIH NIH K23** · BETH ISRAEL DEACONESS MEDICAL CENTER · 2024 · $191,484

## Abstract

PROJECT SUMMARY
From asymptomatic carriage to life-threatening diarrhea and colitis, C.difficile interacts with humans through a
range of phenotypes. The mechanisms underlying this spectrum are incompletely understood. Despite progress
in the understanding of the disease and the advent of newer therapies, patient outcomes such as failure to
respond promptly to therapy (~20%), recurrence (~21%), death, colectomy or need for critical care (severe
outcomes, ~3 %) remain common. As patient-centered outcomes (PCOs) take center stage in clinical research,
C.difficile Infection (CDI) will not be an exception. This Career Development proposal is based on the central
hypothesis that integrated analysis of immune, microbial and metabolic data (IMM/d) from new and existing
cohorts of CDI patients and carriers, by identifying biological markers and pathways, can transform patient
outcomes (especially PCOs) and re-categorize the CDI to colonization continuum (CDI/cc). Javier A. Villafuerte
Gálvez [JVG], MD is an Instructor at Harvard Medical School (HMS) and a gastroenterologist subspecialized in
immune-mediated digestive disease at Beth Israel Deaconess Medical Center (BIDMC). He has gained
substantial experience in clinical and translational research during his post-doctoral and T32 fellowships while
proving commitment to a patient centered research career.
This Award will provide the applicant with the opportunity to develop quantitative analysis skill while taking full
advantage of mentored research opportunities to address knowledge gaps in prediction, classification and
pathobiology of CDI. Dr. Ciarán P. Kelly, an expert in CDI and bowel inflammation will serve as mentor, along
with Dr. Yang-Yu Liu, an expert in bioinformatics studying the dynamics of the human gut microbiome who will
be co-mentor. The Advisory Committee composed by CDI and methodological experts (Drs. Garey, Pollock,
Gerszten and Dubberke) will confer regularly with the applicant to evaluate progress.
The K23 award will aid JVG to establish an independent research program applying bioinformatics tools to unmet
needs in immune-digestive disorders, with CDI as a first model. The backbone of the curriculum will be the
Master in Biomedical Informatics at HMS. Grant writing training and support through Harvard Catalyst will be
critical. The first aim of this project is to identify fecal IMM/d biological markers and pathways at the time of CDI
diagnosis associated with severe outcomes, recurrence and disease trajectory. Informed by this, we will recruit
a new CDI cohort to measure PCOs (symptoms, quality of life) while collecting biospecimens, in order to identify
IMM/d biological markers and pathways predicting and underlying PCOs. Finally, with IMM/d as substrate to
machine learning algorithms blinded to standard diagnostics, we will re-categorize patients in the CDI/cc in new
functional disease groupings. This research will answer critical questions in CDI diagnostics, prognostication and...

## Key facts

- **NIH application ID:** 10933476
- **Project number:** 5K23AI177749-02
- **Recipient organization:** BETH ISRAEL DEACONESS MEDICAL CENTER
- **Principal Investigator:** Javier Andres Villafuerte Galvez
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $191,484
- **Award type:** 5
- **Project period:** 2023-09-22 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10933476

## Citation

> US National Institutes of Health, RePORTER application 10933476, Redefining C.difficile patient outcomes through network medicine (5K23AI177749-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10933476. Licensed CC0.

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