Microbiota Donors

The term fecal transplant often conjures up vivid imagery in patients. However, it is not quite accurate. This is the reason that the terminology has been changed to intestinal microbiota transplantation. Microbiota refers to communities of microbes, which are especially abundant in the lower intestines and can be recovered from feces. We separate the microbiota from the fecal material, measure and characterize it, and store it frozen in a special cryoprotectant solution.

Preparation of fecal microbiota does start with donations. The idea of donating stool is still quite novel. However, the process has many parallels to blood donation, although there are some differences. Potential donors have to be qualified through a rigorous process that screens and tests candidates for infectious risk and beyond. Gut microbiota is an integral part of the human body, involved in many aspects of physiology, including energy metabolism, the immune system, and even behavior. Therefore, the donor program excludes individuals with any gastrointestinal problems, autoimmunity, allergies, as well as metabolic, neurological, and psychiatric disorders. Exposure to antibiotics within 6 months is disqualifying.

Donor Protocol

Specific initial steps for qualification include

• • An extensive questionnaire
  • Complete in-office history and physical examination
  • Laboratory testing (blood and stool)

Donations have to take place in a designated bathroom. The donor checks in with the nurse to ensure there are no active medical problems on each donation visit.

Physical examination, medical history review, and repeated laboratory testing occur every three months.

Donated material is delivered to the Molecular and Cellular Therapeutics Building at the University, where it is processed in a highly standardized fashion to prepare treatment units of microbiota. The units cannot be released for clinical use or clinical trials until all elements of donor qualification and fecal material testing pass quality controls.

Donors in our program save lives! Towards the end of 2022, we have treated and cured ~ 2,500 patients with refractory C. difficile infection who have exhausted all other options. The microbiota is also increasingly used in formal clinical trials for conditions other than C. difficile, and we may discover additional indications.

If you are interested in becoming a donor, please contact our coordinator at fmtstudy@umn.edu.