The capsules contain concentrated formulations of the same rigorously screened and processed microbiota preparations as OpenBiome’s other FMT treatments, Lower Delivery Microbiota Preparation (FMP250) and Upper Delivery Microbiota Preparation (FMP30).
OpenBiome’s patent-pending Microbial Emulsion Matrix (MEM) Technology ensures the long-term physical integrity of the capsule while preserving the viability of the complex microbial communities within.
FMT Capsule DE may be used as a treatment for C. difficile infection not responsive to standard therapies in accordance with the FDA’s guidance on the use of fecal microbiota for transplantation, and in clinical trials under an Investigational New Drug (IND) application.
+ Clinical Evidence of Efficacy
Preliminary evidence for FMT via capsules suggests a 70% clinical cure rate with a single administered dose of 30 capsules, and a cumulative clinical cure rate of 94% if non-responders are retreated with an extended dose of 30 capsules on 2 consecutive days. These results are in keeping with other studies that suggest between a 68-70% clinical cure rate with a single administration of FMT capsules. A recent randomized controlled trial found double-encapsulated FMT to be non-inferior to FMT by colonoscopy.
These results are comparable to previously published investigations of the efficacy of encapsulated FMT. For further details on these case studies, refer to OpenBiome’s FMT Capsule Clinical Primer.
+ Dosage and Delivery
The recommended dose for treatment of rCDI is 30 capsules, swallowed consecutively in a single session.
Capsules are size 00, approximately the size of a large multivitamin. OpenBiome will provide two ‘placebo’ test capsules with each treatment. The patient may be asked to ingest one test capsule prior to the start of treatment, under direct observation of the physician, to ensure the patient’s ability to swallow. Any clinical concerns suggesting an aspiration risk is an absolute contraindication to capsule administration.
Each course of capsules should be kept frozen until the time of administration, and then ingested as quickly as possible after extraction from the freezer. Capsules may be kept at room temperature for up to 90 minutes for patient comfort and ease of swallowing. Capsules should never be refrozen, and should be disposed of if not used within 90 minutes. To mitigate the risks associated with aspiration, we require capsules to be administered under direct observation by a physician.
For further details, including a list of contraindications, please refer to our FMT Capsule Clinical Primer, which outlines a 6-step process including pre-administration preparations.
Providers may also perform FMT either through the lower gastrointestinal tract (e.g. by colonoscope/sigmoidoscope or enema) or through the upper gastrointestinal tract (e.g. by nasogastric/nasoduodenal tube) using other OpenBiome microbiota preparations. For more detailed instruction on these routes of modality, please see Clinical Guidance. Each route of administration carries unique risks and benefits, so it is important to select the appropriate mode of delivery for your patient's health condition.
+ Patient Preparation
Informed consent: Before administering FMT capsules, it is critical to inform patients of both procedural and microbiota transference-related risks. When obtaining informed consent, physicians must let the patient know that the use of FMT products to treat C. difficile infection is investigational, and discuss alternative treatment options such as alternative routes of administration, long-term vancomycin therapy, surgery, and no treatment at all. You may find our Pre-FMT Patient Guide a helpful educational resource.
48 hours before treatment: While evidence is limited, standard practice includes discontinuation of anti-C. difficile antibiotics two days before FMT. This will ensure that antibiotics do not impact the newly transferred microbiota.
+ Patient Discharge and Follow-Up
It is paramount to follow-up with patients to monitor for adverse events and evaluate whether resolution of C. difficile has occurred. Standard clinical practices suggests a clinic visit 8-weeks post-FMT for assessment. A physician or their delegate should also conduct telephone follow-up assessments post-FMT at short (Week 1) and intermediate (Week 4) time points.
After all follow-ups are completed, send OpenBiome’s mandatory FMT Follow-Up Form and Material Tracking Log to firstname.lastname@example.org, or fax to (617) 575-2201, updating the status of treatments in your inventory and reporting de-identified patient outcomes at each of the aforementioned time points.
Certain symptoms such as changes in bowel habits, abdominal pain, bloating and cramping are common after FMT, but these side effects are transient. Patients should be instructed about when to seek medical attention for potential adverse events. Additionally, patients should receive educational material on ways to reduce the risk of C. difficile re-infection. OpenBiome's Post-FMT Patient Guide provides helpful information about how to properly disinfect one's home and guidance about future antibiotic use.
+ Storage and Handling
Each shipment of FMT capsules will be delivered on dry ice in temperature-controlled packaging. They should be frozen immediately upon arrival in a medical-grade freezer at -20°C or colder, and kept frozen until they are ready to be used by a patient. Capsules can be stored at this temperature for 6 months. If at any point capsules are removed from the freezer during an occasion in which they are not administered to a patient, they must be returned to the freezer within 10 minutes or otherwise discarded.
When capsules are removed from the freezer for administration, the bottle should be opened right away and the pills consumed by the patient within 90 minutes. Past 90 minutes of exposure to room temperature conditions, they should be discarded. Please see our Storage Controls and Material Specifications for additional information.
+ Pricing and Ordering
Pricing: Each recommended dose of 30 capsules plus a safety test capsule costs $635. OpenBiome’s standard shipping charges and policies apply.
Placing an Order: Registered OpenBiome partners may order FMT Capsule DE for clinical use by submitting either the OpenBiome Order Form or their own Purchase Order by email to email@example.com (preferred) or by fax to 617-575-2201. Prior to a facility's first order of capsules, an orientation with the treating physician is required to review the unique clinical considerations of encapsulated oral FMT administration. Please contact our Clinical Outreach team by phone at 617-575-2201 or email at firstname.lastname@example.org to arrange this orientation.
Pro-Bono Treatments: OpenBiome is committed to facilitating universal safe access to FMT. With generous support from the Anne Marie and Stephen Kellen Foundation, we are able to offer a limited number of pro-bono treatments for any patients who are unable to cover the costs of material.
Physicians and researchers interested in learning more about ordering and availability can contact OpenBiome at email@example.com for more details. As per the policy for all methods of administration, OpenBiome only ships FMT material to physicians for the treatment of rCDI, unless the procedure is being performed under an IND.
+ Material Tracking and Reporting
Tracking the safety and efficacy of our material is a vital component of OpenBiome's Quality & Safety Program. This program allows us to continuously monitor the efficacy and safety of our treatments on a per-donor basis, and effectively respond to suspected adverse events in a timely manner. Additionally, the U.S. Food and Drug Administration (FDA) considers stool for fecal microbiota transplantation (FMT) an investigational drug, a classification that carries certain reporting requirements. We aggregate and share your submissions to our material tracking program with the FDA.
Our material tracking program has three constituent parts, each of which is instrumental to patient safety and complying with FDA reporting requirements:
Material Tracking Logs
A Material Tracking Log (MTL) listing the units released to your facility will be included with every shipment you receive from OpenBiome. We use this log to facilitate inventory tracking across our network. As units are received, stored, and eventually used in procedures, their status should be documented on your MTL, which must be submitted by the time you place your next order.
FMT Follow-Up Forms
An FMT Follow-Up Form must be completed for each patient that receives an FMT from OpenBiome. It requests de-identified patient specifics, including delivery modality, disease severity, and the treatment outcome. This form should be given to the administering physician or their staff at the time of treatment and returned to OpenBiome after the patient’s 8-week follow-up has been completed.
Reporting Adverse Events
If you suspect one of your patients has experienced an adverse event that could be related to an OpenBiome FMT treatment, please fill out and submit OpenBiome's online Adverse Event Reporting Form within 24 hours to alert our Clinical Safety Team. Please review this checklist to ensure you have the necessary information ready to complete your report. Once submitted, an OpenBiome medical professional will contact you to discuss the specifics of your case and advise whether additional reporting requirements to the FDA may be needed.
We take great care in rigorously screening our donors through a clinical assessment by our medical staff and stool and serological testing in a CLIA-certified laboratory. However, in the case that a serious adverse event does occur, OpenBiome has established a series of actions that are triggered in response to your report. This decision algorithm allows us to coordinate timely and comprehensive investigations with our clinical partners, including submission of the Form FDA 3500A, when necessary.
If you have any questions regarding an adverse event, please contact us at firstname.lastname@example.org or call (617) 575-2201, option 1. Our Clinical team is more than willing to discuss the specifics of your adverse event case.
For more information about what data to collect and submit on each form, please see our guide for material Monitoring and Traceability. If you have any additional questions about this reporting system, please contact us at email@example.com or call 617-575-2201, option 3.
+ Contact Information
General, Clinical Use, and Ordering Questions: firstname.lastname@example.org or (617) 575-2201
Research: email@example.com or (617) 575-2201
Quality Assurance & Safety Reporting: firstname.lastname@example.org or (617) 575-2201
Submission of Form 3500, Non-Response Reporting Forms, or Material Tracking Logs: Email forms to email@example.com or fax forms to 617-575-2201
FDA Adverse Event Reporting: Fax FDA MedWatch Form 3500 to 800-FDA-0178 or mail form to:
The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20852-9787