Introduction
Fecal microbiota transplantation (FMT) is an effective therapy for recurrent Clostridioides difficile infection. A pool of healthy stool donors is essential for any FMT program. However, donor
recruitment is not easy due to screening failures and the commitment requested.
Aims & Methods
We aimed to report data from the first two years of stool donor screening, recruitment, and stool banking from the first public Italian FMT center. We prospectively collected data from donor screening questionnaires, laboratory evaluations, and donations. Donor screening has been performed according to the Italian Health Ministry regulation and the FMT European consensus FMT (1): potential donors, all aged below 50 years old, were initially screened for the presence of concomitant gastrointestinal and systemic diseases or for the anamnestic drugs intake or recent antibiotic intake. The subsequent clinical evaluation aimed at excluding at-risk conditions for infectious diseases, while the microbiological screening evaluated the colonization by potential pathogens. Bacterial counts in terms of aerobes and anaerobes concentration [colony forming unit (CFU)/mL] from aliquots of each frozen fecal material after aerobic samples preparation were assessed after 1 week and subsequently monthly until 18 months from the donation.
Results
Two hundred and 12 patients completed screening questionnaires. Of these, 29 (13.7%) were excluded for concurrent gastrointestinal symptoms (altered bowel habits) or diseases, 50 (23.6%) for concomitant systemic diseases, and 8 (3.8%) for antibiotic intake in the previous 6 months. Finally, of the 120 donors clinically evaluated, 79 (37.3%) were excluded for at-risk conditions for infectious disease (e.g., use of illegal drugs, risky sexual behavior, recent body tattoo, piercing, travel in tropical countries, healthcare workers, etc.). Among the remaining 41 donors microbiologically screened, 19 (9%) were excluded for pathogens or potential pathogens presence (6 pathogenic Escherichia coli, 1 Vancomycin-resistant Enterococci, 2 Helicobacter pylori, 1 Rotavirus, 1 Giardia, and 8 for other reasons). Finally, 22 subjects (10.4%) were suitable for donation. Among the 10 healthy donors actively donating stools (50% females), 6 were excluded for pathogens infections diagnosed during donation screenings after a median of 3 donations (3 pathogenic Escherichia coli, 1 Salmonella enterica, 1 Campylobacter jejuni, 1 Cryptosporidium). Among the remaining 4 subjects, 2 discontinued the donation program due to the commitment requested. Finally, 22 subjects (10.4%) were suitable for donation. Ten healthy donors actively donated stools (50% females), but 6 were excluded for pathogens/potentially pathogenic bacteria diagnosed during donation screenings after a median of 3 donations. Among the remaining 4 subjects, 2 discontinued the donation program due to the commitment requested.
Aliquots evaluation showed no differences in aerobic counts until 18 months, while significant differences were found for anaerobic counts already after 1 month (1.33x10^10 CFU/mL vs 7.6x10^9 CFU/mL at donation and after 1 month, respectively, p=0.028).
Conclusion
Only one in ten potential healthy donors is finally eligible for stool donation. Frozen stool samples showed a significant decrease in anaerobic concentration already after 1 month from storage, compared to fresh material.
References
1. Cammarota G., et al. Gut. 2017 Apr;66(4):569-580.
Disclosure
Lecture grants from EG Pharma, AlfaSigma, Bromatech, Echosens, Ferring, Mayoly Spindler and Schwabe Pharma.
