Forms & Guides

This page serves as a one-stop-shop for forms that will help you access Investigational Fecal Microbiota Transplantation (FMT) Preparations distributed by OpenBiome as well as fulfill follow-up reporting requirements.

Place An Order

From Registration to Follow-Up Reporting

This resource will support your journey from becoming an OpenBiome clinical partner, to placing an order, to administering investigational treatment and reporting patient outcomes.

Joining our Clinical Network

Before placing an order, your practice or medical facility must complete a clinical registration form and return it to our clinical outreach team. We must have an account on record for every location to which we ship, including individual facilities within the same health system.

Files

Clinical Registration Form for Partners Using Investigational FMT Preparations Manufactured by the University of Minnesota (PDF)

Ordering Material and Shipping

OpenBiome typically processes orders the day after we receive them and ships investigational FMT preparations overnight on dry ice at approximately -20 degrees Celsius.

Files

OpenBiome Order Form (PDF)

Storage Controls and Material Specifications for UMN-manufactured Investigational FMT preparations (PDF)

Administering Investigational FMT

The following clinical inserts provide instructions on storing, thawing, and administering each investigational FMT preparation formulation.

Files

Clinical Insert for MTP-101LR (PDF)

Clinical Insert for MTP-101LF (PDF)

Follow-Up Reporting

OpenBiome gathers data on patient outcomes after they receive an investigational FMT preparation. This allows us to continuously monitor the efficacy and safety of the investigational preparations on a per-donor basis, and effectively respond to suspected adverse events in a timely manner.

Files

For research partners using UMN-manufactured investigational FMT preparations, report follow-up data to the Investigational FMT Outcomes Registry (Online Form)

Adverse Event Reporting

As part of our commitment to enable safe access to accountable, high-quality investigational FMT preparations, all clinical partners that utilize investigational FMT material distributed by OpenBiome are required to report adverse events (AEs) to OpenBiome and possibly to the FDA.

Files

Immediately Report Any Adverse Events Here

Adverse Event Reporting Checklist: Consult This Checklist Prior to Reporting an Adverse Event to Ensure That All Relevant Information is Submitted (PDF)

FDA MedWatch Form 3500: The Form Investigational FMT Providers Should Submit to the FDA and OpenBiome in the Case of a Serious Adverse Event (PDF)

Patient Support

Patients can take several simple steps to prepare for their investigational FMT and increase their chances of recovery.

Files

Patient Guide: A scheduling and cleaning guide for patients preparing for an Investigational FMT procedure (PDF)

Patient Guide: A guide for patients to minimize chances of C.dff reinfection after an Investigational FMT procedure (PDF)

Request an Investigator's Brochure

OpenBiome and The University of Minnesota maintain Investigator's Brochures for FMPCapDE, MTP-101LR, and MTP-101LF. To request access to an Investigator's Brochure please fill out the following form.

Files

Investigator's Brochure Request Form

Need more?

If you don't see a form or resource that you need, please don't hesitate to email info@openbiome.org. We are here to help you find what you are looking for.

The OpenBiome Clinical Team

info@openbiome.org

617-575-2201, option 3

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