Obstacles to donor recruitment for faecal microbiota transplantation - Experiences from the FOCUS study

Introduction: The increasing interest and demand for faecal microbiota transplantation (FMT) has created a need for a bank of long-term healthy donors. Here, we describe our experience in recruiting and screening faecal donors for our clinical trial, the FOCUS Study. Methods: Recruitment of potential healthy faecal donors included letterbox, newspaper, and online advertisements. Financial reimbursement for out-of-pocket expenses, as agreed by Ethics Committee, was offered. Potential donors were required to satisfy a pre-screen telephone conversation, perform and pass comprehensive blood and stool screening investigations, then undertake a final detailed screening interview including medical history, physical examination, and evaluation of donor selection criteria. Results: A total of 116 potential donors were pre-screened over a 7-month period after responding to donor advertisements. Seventy-four failed pre-screening, 47 declined based on study donation requirements, 13 had medical comorbidities, 6 had vCJD risk factors, 1 had recent antibiotic use, and 7 failed for other reasons. Thirty-eight healthy potential donors completed stool and blood testing, of whom 1 failed blood testing due to indeterminate hepatitis C serology, 15 failed stool testing (5 Dientamoeba fragilis, 5 Blastocystis hominis, 1 B. hominis and D. fragilis, 1 Giardia intestinalis plus D. fragilis, 1 Norovirus and Clostridium difficile-toxin positive, and 2 had leucocytes or erythrocytes on stool microscopy). Of 22 remaining potential donors, 2 were excluded due to interim antibiotic use and 1 was living with a household member who was positive for D. fragilis. Of the remaining 19 potential donors, 18 completed the final screening visit, but 6 were excluded (3 due to BMI >30, 1 due to illicit drug use, 1 due to uncontrolled anxiety / depression and 1 due to irregular bowel movements after new medication commencement). In total, only 12 (10%) of 116 potential donors were enrolled as study donors. Conclusion: Recruitment of healthy faecal donors for FMT is challenging and was associated with only a 10% success rate. Nearly half of the potential donors were unable or unwilling to meet the donor commitment requirements. A surprisingly large proportion of healthy and asymptomatic donors failed stool testing, primarily due to gastrointestinal parasites. Disclosure - Thomas J. Borody has a pecuniary interest in the Centre for Digestive Diseases, where faecal microbiota transplantation is a treatment option for patients and has filed patents in this area.