The Netherlands Donor Feces Bank a. it takes stool to get better
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1 The Netherlands Donor Feces Bank a it takes stool to get better H.W. Verspaget Dept. of Biobanking and Dept. of Gastroenterology Leiden University Medical Center The Netherlands
2 Fecal MicrobiotaTransplantation (FMT) for Clostridium difficile infection Very effective therapy for recurrent C. diff infection In NL patients with recurrent C. diff per year Van Nood: NEJM 2013
3 Donors Bottlenecks donor feces bank: Donor selection + screening Feces suspension as a product Logistics Costs
4 Scrutinous donor screening Questionnaire: Risk assessment 1. Transmissible diseases 2. Illnesses associated with disturbed microbiota Exclusion criteria: Age <18 or 50, BMI <18.5 or > 25, high risk fecal- and or blood transmittable diseases, recent antibiotic use (<6 months), gastrointestinal complaints, recent travel to endemic areas of GI pathogens, (close relative with) inflammatory bowel disease or GI malignancy, substantial comorbidity, various medication Laboratory screening serum Hepatitis A (IgM + IgG) Hepatitis B (HBsAg + anti-hbcore) Hepatitis C (anti-hcv) Hepatitis E (IgM + IgG) HIV (anti-hiv, type 1 and 2) Lues (Ig) Cytomegalovirus (IgM + IgG Epstein Barr Virus (IgM + IgG Strongyloïdes (IgG1/IgG4) 1 1 If travel history to South America, Africa or Asia Laboratory screening feces Clostridium difficile (TcdB PCR) Helicobacter pylori (antigen test) Bacterial gastro-enteritis (PCR + culture: Salmonella spp. Campylobacter jejuni and C. coli, Shigella spp., Yersinia enterocolitica and Y. pseudotuberculosis, Aeromonas spp. and Plesiomonas shigelloides) Shiga-toxin producing E.coli (Stx1/Stx2/EscV) Multidrug-resistant micro-organisms; ESBL and/or carbapenemase producing and/or quinolone and aminoglycoside resistant Gram negatives, VRE, MRSA Virus: Norovirus serotype I+II, Astrovirus, Sapovirus, Rotavirus, Adenovirus 40/41, Adenovirus non-40/41, Enterovirus, Parechovirus Parasites: Giardia lamblia, Entamoeba histolytica, Cryptosporidium parvum and C. hominis, Microspiridium, Dientamoeba fragilis, Blastocystis hominis, Strongyloides 1 Short questionnaire every donation: recent health-related issues: Stool frequency/pattern, general health, use of antibiotics, travel history, sexual behaviour % 71 43% % % 4 2.4% Terveer: CMI 2017 in press
5 FMT procedures 60 gram donor feces < 2h after defecation Homogenization: saline, mortar/pestle, sieve, centrifugation 10% end concentration glycerol (cryoprotectant) Storage -80⁰C Quality control: suspension 2cc Quality control: feces Fecal suspension 198cc Quarantine 2 months Evaluation of eligible patients by NDFB working group Distribution by Biologistic courier Training, treatment protocol and follow-up (incl. feces collection) Biovigilance registration
6 FMT procedures May 2016 April 2017: 30 FMTs for recurrent C. diff 17 NL-hospitals 12x FMT research (MDRO/IBS) 4 C. diff recurrences (13,3%) = cure rate 86,7% 2 explained by continued antibiotic use All treated successfully with vancomycin/fidaxomicin Adverse events: 1x regurgitation donor feces, 3 hrs after FMT 1x death; 1 week after FMT due to Hospital Acquired Pneumonia (HAP) Since April 2017: 14 additional FMTs for rc. diff, evaluation in progress
7 Diseases with disturbed intestinal microbiota suitable for FMT Autism HIV Diabetes Obesity Cancer Heart disease Gut bacteria Liver disease Kidney disease Rheumatic disease Parkinson s disease Inflammatory bowel disease Clostridium difficile infection Sivan et al., Science 2015 Zhang et al., Int. J. Mol. Sci. 2015
8 Working group NDFB Daily board: Dr. JJ Keller Prof. dr. EJ Kuijper Gastroenterologist, MCH-Bronovo & LUMC Medical microbiologist, LUMC Working group: Drs. EM Terveer Prof. dr. ir. HW Verspaget Dr. MP Bauer Drs. YH van Beurden Prof. dr. CMJE Vandenbroucke-Grauls Prof. dr. CJJ Mulder Dr. E van Nood Dr. A Goorhuis Dr. MGW Dijkgraaf Dr. J Seegers Prof. dr. WM de Vos Medical microbiologist, LUMC Cell biologist Gastroenterology - Biobank, LUMC Internist, LUMC PhD candidate Gastroenteroloy, VUmc Medical microbiologist, VUmc Gastroenterologist, VUmc Internist, Havenziekenhuis Infectious diseases specialist, AMC Research methdologist, AMC Moleculair Biologist, consultant Microbiologist, Wageningen University Medical advisory board: Em. prof. dr. JE Degener Em. prof. dr. P Speelman Medical microbiologist Infectious diseases specialist
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