1. FMT for Children with Recurrent Clostridium difficile Infection George Hylands Russell, MD, MSc 2014 James W. Freston Conference Chicago, Illinois August 17, 2015

2. I have no financial relationships with any commercial entity to disclose

3. Plan A special population A quick look at the literature NASPGHAN next steps

4. How is Pediatric RCDI different? C. diff is constitutive flora until after 6 months of age, 10 % carriage rate at 1 year 10 fold rise in incidence from 1991-2009 Refractory C. diff is rare. Recurrence risk is about 22-30% as in adults. Community acquired C. diff is more common than in adults 23-43% lack antimicrobial exposure history Up to 38% of previously healthy children with RCDI have NAP1/B1/027 serotype Benson L, et al. Infect Control Hosp Epidemiol. 2007;28(11):1233–1235. Khanna S BL, et al. Clin Infect Dis. 2013;56(10):1401-1406. Janqi S, et al. JPGN. 2010; 51:2-7.

5. A special population A vulnerable population Potential life-long ramifications? Long-term safety is a longer term concern Registry and follow up data on outcomes and health status particularly interesting and important

6. Pediatric index case 24 month old girl with community acquired RCDI (6 recurrences) Nasogastric tube delivery Healthy screened paternal donor Safe and well in 24 hours now with 5 years f/u Russell GH, et al. Pediatrics. 2010; 126: e-239-242.

7. 16 month old with community acquired RCDI (6 recurrences) that began at 11 mos of age after Azithromycin for bronchitis 1 st pediatric case documented with colonoscopic delivery Testing and delivery by FMT Working Group Guidelines (Baaken J, et al. Clin Gastro Hep. 2011; 9:1044-1049) Improvement in 24 hours. Safe and well in F/U Kahn S, et al. AmJGastro. 2012; 107: 1930-1.

8. Largest pediatric case series Patients who received FMT for RCDI between 2009-2013 at MGH for Children 2 nasogastric tube delivery/ 8 by colonoscopic delivery 90% success rate Safe in patients with and without Inflammatory Bowel Disease Russell GH, et al. JPGN. 2014; 58(5): 588-592.

11. Counted as a failure Redeveloped CDI after re-admission

12. Russell GH, et al. JPGN. 2014; 58(5): 588-592. Admitted for severe acute colitis RCDI vs UC 100% better for 5 days then resumed severe bloody diarrhea Never redeveloped CDI Potential fulminant UC flare secondary to FMT?

13. Russell GH, et al. JPGN. 2014; 58(5): 588-592.

14. Role of colonization and the sensitivity of the PCR test No change in symptoms occurred (even when RCDI was cleared) when RCDI was not clearly causative

15. Columbia experience – Ahead of Print 6 patients with at least 2 RCDI – 4 of whom had comorbidities: IBD, Hirschsprung disease, G-tube dependence Cure rate of 100% All screened parent donors – all received PEG 17 grams BID x 2 days. All by colonoscopy following general FMT Working Group guidelines (Baaken J, et al. Clin Gastro Hep. 2011; 9:1044-1049) Potential adverse effect in patient with IBD (developed appendicitis after FMT) Pierog A, et al. JPGN. 2014; 10.1097/INF.0000000000000419.

16. NASPGHAN has sponsored the FMT Special Interest Group Standardize pediatric FMT protocols – Standardize recipient/donor consents – Standardize minimal donor testing – Educate and communicate with the Pediatric GI community – Liaison with adult groups and other professional organizations