White Papers

This living repository is designed for physicians and patients looking to learn more about C. difficile infections and investigational fecal microbiota transplantation.

This white paper collection shares OpenBiome's expertise and experience serving patients with C. difficile infections. The collection is organized into three sections that highlights information physicians and patients should consider before, during, and after an investigational fecal microbiota transplantation.

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Have an idea for a white paper? Please email info@openbiome.org.

We’d love to hear from you and discuss how to get involved.

The guidance presented below are general principles drawn from the experience and medical opinions of OpenBiome’s Clinical team. Physicians should use their own discretion when evaluating their patients and consider each patient’s unique medical needs.

Investigational fecal microbiota transplantation (FMT) is not an FDA-approved therapy. Physicians and patients should determine whether an investigational FMT is a suitable treatment option depending on the patient's unique medical history and treatment goals.

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Preparing for an Investigational Fecal Microbiota Transplantation (FMT)

Investigational Fecal Microbiota Transplantation (FMT) has been shown to treat 80-90% of C. difficile infections not responsive to antibiotic therapy in clinical trials and real-world settings. However, the utility of FMT depends on accurate CDI diagnosis and patient selection. As many as 25% of patients may be incorrectly referred for FMT. This paper covers the considerations when evaluating patients for FMT for the treatment of C. difficile infections.

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Controlled clinical trials and observational studies of Fecal Microbiota Transplantation (FMT) as a treatment for C. difficile infection (CDI) have reported cure rates ranging from 68%-100%. However, such trials and studies have varying definitions of recurrent C. difficile, use different FMT formulations and delivery methods, and treat different patient populations. This paper reviews important points to consider when extrapolating existing efficacy data to the unique situation of an individual patient.

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Administering Investigational Fecal Microbiota Transplantation (FMT)

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Recovery After an Investigational Fecal Microbiota Transplantation (FMT)

Detection and response to reported safety events is one of a stool bank's most important roles. A robust material tracking and pharmacovigilance program enables timely responses to suspected adverse events including safety measures to mitigate risk to patients receiving FMT at centers being supplied by the stool bank. This paper presents OpenBiome's material tracking and pharmacovigilance program as an example for surveilling patient responses to FMT.

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