SPREADING AWARENESS OF CLINICAL TRIALS


Fecal Microbiota Transplantation (FMT) is an investigational treatment. The Food & Drug Administration (FDA) regulates FMT as an investigational drug. FMT may currently be used to treat recurrent C. difficile infection under an interim policy of ‘enforcement discretion’.

More research is needed to ensure that patients will continue to have access to FMT and similar microbiome-based treatments. This research will build a greater body of evidence to determine the long-term safety and efficacy profile of FMT. The FDA may use this information to approve a specific product or to inform the regulations governing the use of FMT.

How can you help? Talk to your patient about their interest in participating in clinical research or clinical trials.

National FMT Registries

Patients who receive FMT may be eligible to participate in the American Gastroenterological Association’s FMT National Registry. The Registry will assess short- and long-term patient outcomes associated with FMT by tracking 4,000 patients over ten years. The AGA is collaborating with OpenBiome and the American Gut Project on this study. 

Pediatric patients may also be eligible to participate in the National Pediatric FMT Registry.

Clinical trials investigating microbiome-based therapies for treating C. difficile

This publicly-available information has been compiled by OpenBiome to serve as an informational resource to clinicians and patients with C. difficile.

We update this page regularly, but new trials begin often and this page may not be all-inclusive; please visit ClinicalTrials.gov for the most up-to-date information. We enthusiastically welcome participation from any academic or industry group conducting clinical trials investigating microbiome-based therapies for treating C. difficile. If you would like to add a trial to this list, please contact media@openbiome.org.

Please contact trial sponsors for additional trial-specific details.

Participating in clinical trials is voluntary. Patients have the right not to participate, or to end their participation in the clinical trial at any time. Ask questions about any information you don’t understand or find confusing. 

Trial Sponsor Trial Description Eligibility Contact Information

Boston Medical Center

FMT for primary CDI First CDI episode Contact: tamar.barlam@bmc.org
Click Here for Trial Information

Brigham and Women's Hospital

FMT + Bezlotoxumab for patients with CDI and IBD 2+ CDI episodes, IBD Contact: jhurtado@bwh.harvard.edu
Click Here for Trial Information

Finch

Oral Capsule to treat
recurrent CDI
2+ CDI episodes Contact: PRISM3trial@finchtherapeutics.com
Click Here For Trial Information

NIH

Enema to treat recurrent
CDI
2+ CDI episodes Contact: nroupha@emory.edu
Click Here for Trial Information

U of Wisconsin, Madison

FMT for CDI in Solid Organ Transplant Recipients 1+ CDI episodes, solid organ transplant recipient Contact: mlzimbri@wisc.edu
Click Here for Trial Information

U of Wisconsin, Madison

Preventing CDI in high risk patients (GRAFT study) 1+ CDI episodes, currently on antibiotics Contact: mlzimbri@wisc.edu
Click Here for Trial Information

Vedanta

Oral Capsule to treat
recurrent CDI
2+ CDI episodes Contact: dtilton@vedantabio.com
Click Here for Trial Information

Note: There are two additional industry-sponsored trials investigating microbiome-based therapies for treating recurrent C. difficile; they have declined to participate in this initiative. You may learn more at ClinicalTrials.gov.

Find a Clinical Trial for treating C. difficile infection

Use the map below to find the closest trial sites to you. Please contact the trial coordinators directly for more information about eligibility and enrollment.

Does OpenBiome have any stake in these clinical trials?

OpenBiome is collaborating on several of the CDI trials listed here, including Boston Medical Center, Brigham & Women’s Hospital, NIH, and University of Wisconsin, Madison. OpenBiome is also collaborating with one of the industry groups listed in this guide, Finch Therapeutics, which you can learn more about here: www.openbiome.org/finch-collaboration/, and is collaborating with the American Gastroenterological Association on the FMT National Registry. Learn more here.

OpenBiome is committed to providing safe access to FMT for C. difficile patients. Since current FDA guidelines consider FMT an investigational treatment, we believe the best option for long term access for patients is for industry groups to seek FDA approval for FMT or a similar microbiome-based treatment.