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FMT in Pediatric IBD

FMT in Pediatric IBD. Michael Docktor, MD Boston Children’s Hospital August 16, 2014. Disclosures . I have no relevant disclosures or financial obligations. Outline. Brief background Anecdotal experience at Boston Children’s Oh and by the way, they have IBD

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FMT in Pediatric IBD

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  1. FMT in Pediatric IBD Michael Docktor, MD Boston Children’s Hospital August 16, 2014

  2. Disclosures • I have no relevant disclosures or financial obligations

  3. Outline • Brief background • Anecdotal experience at Boston Children’s • Oh and by the way, they have IBD • Pediatric FMT in ulcerative colitis • Pediatric FMT in Crohn’s disease • Future directions

  4. Kostic, et al. Gastro. 2014; 146(5): 1489-1499

  5. Our experience: FMT for IBD“Innovative Therapy” • 7 patients with recalcitrant IBD • Ages 12-17 yrs. (average 15 yrs.), 3 M / 4 F • 4 UC, 2 CD, 1 IC • Related donor FMT via colonoscopy and f/u home enemas • All seven were recommended escalation of therapy • 85% (6/7) recommended Tacrolimus +/- surgical colectomy • All 6 were steroid dependent at time of FMT • 15% (1/7) recommended addition of a biologic • Docktor M, et al. Unpublished data 2011-2013

  6. Our experience: FMT for IBD“Innovative Therapy” • 85% (6/7) stabilized and were weaned from steroids • 57% (4/7) improved but remained stable on previous therapy • 28% (2/7) discontinued steroids, biologic and 6-MP • 1 in deep clinical remission on 5-ASA & Vancomycin 2+ years • 1 with mild activity, de-escalated to 5-ASA • 15% (1/7) continued to slowly worsen, Tac  surgical colectomy 9 months later • No adverse events reported, all procedures and f/u well tolerated up to 2.5 years out. • Docktor M, et al. Unpublished data 2011-2013

  7. Microbial analysis of FMT • Docktor M, et al. Unpublished data 2011-2013

  8. 10 children with RCDI (1-19 years) • Open label single, related FMT via NG tube (2) or colonoscope (8) • 3/10 patients had concomitant IBD • Overall success rate 90% for curing RCDI • 7/7 (100%) among non-IBD patients • 2/3 (66%) among IBD patients • Russell GH, et al. JPGN. 2014; 58(5): 588-592.

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

  10. 11 y/o M with CD • Counted as failure • Redeveloped CDI after re-admission 2 months • Russell GH, et al. JPGN. 2014; 58(5): 588-592.

  11. 19 y/o F with UC • Admitted for severe, acute colitis • 100% better for 5 days then severe bloody diarrhea • Never redeveloped CDI • Potential fulminant UC flare secondary to FMT? • Russell GH, et al. JPGN. 2014; 58(5): 588-592.

  12. Fecal Microbiota Transplantation in Children with Recurrent Clostridium difficileInfection Anne Pierog, MD, Ali Mencin, MD, and NorelleRizkalla Reilly, MDColumbia University Medical Center, Division of Pediatric Gastroenterology, Hepatology and Nutrition • 6 patients with RCDI • Ages 4-21 yrs., 4 M / 2 F • 1CD, 1 IC • Related donor FMT via colonoscopy • 100% cure rate for C. diff • 12 y/o M with CD • Initial clinical improvement @ 1 week • Acute appendicitis @ 2 weeks post FMT • Clinical “remission” with optimized therapy @ 12 weeks • Follow up: both IBD patients cured of CDI, required escalation of IBD therapy • Pierog A, et al. PedsInfec Dis Journ. Accepted for publication.

  13. FMT for PEDIATRIC Ulcerative Colitis

  14. Safety and tolerability of FMT via enema in 9 children w/ UC • 7 – 21 years, mild-moderate disease (PUCAI 15-65) • Daily enemas x 5 days • 78% (7/9) showed clinical response within 1 week • 67% (6/9) maintained clinical response at 1 month • 33% (3/9) achieved clinical remission at 1 week • FMT via enema was feasibleand tolerable in children with limited side effects. Kunde S, et al. JPGN 2013 Jun;56(6):597-601

  15. Kunde S, et al. JPGN 2013 Jun;56(6):597-601

  16. Fecal Microbial Transplant via Nasogastric tube for active Pediatric Ulcerative ColitisDavid L. Suskind1 M.D., Namita Singh2 M.D., Heather Nielson, Ghassan Wahbeh1 M.D., • Open label single FMT via NG tube • Four male patients, 14.5 ± 1.7 years • Pretreatment with Rifaximin TID x 3 days • Follow up @ 2, 6, 12 weeks • Mild symptoms including vomiting and bloating • 2/4 developed C.diffwithin 4 months (1 recurrence) • No change in PUCAI, CRP, albumin, HCT • Overall safe but not efficacious • Suskind D, et al. JPGN. Accepted for publication.

  17. FMT for PEDIATRIC CrohN’s DISEASE

  18. Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohn’sdiseaseDavid L. Suskind MD1, Mitchell J. Brittnacher PhD2, GhassanWahbeh MD1, Michele L. Shaffer PhD1, Hillary S. Hayden2,Namita Singh MD3, Christopher J. Damman MD4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD2,4,5,6 • Nine pediatric patients • Mild to moderate Crohn’s(PCDAI of 10-29) • 12-19 years • Open label NGT delivery of related donor FMT • Studied • Clinical response (PCDAI, CRP, calprotectin) • Engraftment & % similarity to donor • Microbial changes • Suskind DL, et al. Seattle Children’s Hospital. Data in submission for print.

  19. Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohn’sdiseaseDavid L. Suskind MD1, Mitchell J. Brittnacher PhD2, GhassanWahbeh MD1, Michele L. Shaffer PhD1, Hillary S. Hayden2,Namita Singh MD3, Christopher J. Damman MD4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD2,4,5,6 • Suskind DL, et al. Seattle Children’s Hospital. Data in submission for print.

  20. Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohn’s disease David L. Suskind MD1, Mitchell J. Brittnacher PhD2, GhassanWahbeh MD1, Michele L. Shaffer PhD1, Hillary S. Hayden2,Namita Singh MD3, Christopher J. Damman MD4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD2,4,5,6 • 7/9 (78%) Had PCDAI fall < 10 @ 2 weeks • 2 required escalation of Rx • 5/7 (71%) Remained < 10 @ 12 weeks • No or modest improvement in patients without engraftment • More divergent = better engraftment and response • Suskind DL, et al. Seattle Children’s Hospital. Data in submission for print.

  21. Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohn’sdiseaseDavid L. Suskind MD1, Mitchell J. Brittnacher PhD2, GhassanWahbeh MD1, Michele L. Shaffer PhD1, Hillary S. Hayden2,Namita Singh MD3, Christopher J. Damman MD4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD2,4,5,6 Recipient Similarity to donor % Time relative to FMT (days) • Suskind DL, et al. Seattle Children’s Hospital. Data in submission for print.

  22. Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohn’sdiseaseDavid L. Suskind MD1, Mitchell J. Brittnacher PhD2, GhassanWahbeh MD1, Michele L. Shaffer PhD1, Hillary S. Hayden2,Namita Singh MD3, Christopher J. Damman MD4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD2,4,5,6 Engraftment score (% ) Time relative to FMT (days) • Suskind DL, et al. Seattle Children’s Hospital. Data in submission for print.

  23. Fecal microbial transplantation in a one-year-old girlwith early onset colitis - caution advisedVandenplasY, Veereman G, van der Werff ten Bosch J, A. Goossens, PierardD, SamsomJN, Escher JC • Vandenplas Y, et al. JPGN. 10.1097/MPG.0000000000000281.

  24. Vandenplas Y, et al. JPGN. 10.1097/MPG.0000000000000281.

  25. From healthy age matched niece Every 2 weeks FMT 7- 14 days of remission • Vandenplas Y, et al. JPGN. 10.1097/MPG.0000000000000281.

  26. From older brother • Vandenplas Y, et al. JPGN. 10.1097/MPG.0000000000000281.

  27. FMT FMT From older brother FMT • Vandenplas Y, et al. JPGN. 10.1097/MPG.0000000000000281.

  28. FMT Remission 1 month FMT From older brother FMT • Vandenplas Y, et al. JPGN. 10.1097/MPG.0000000000000281.

  29. FMT Remission 1 month FMT 2 months From older brother Remission 2 month FMT • Vandenplas Y, et al. JPGN. 10.1097/MPG.0000000000000281.

  30. FMT Remission 1 month FMT 2 months From older brother Remission 2 month FMT 2 months Remission 6 month

  31. Clinical Trials • NCT01096635 – DBPCT using FMT to treat chronic active UC (Padaramothy, New South Wales) • NCT02049502 – FMT to treat active UC associated post-IPAA pouchitis(Shaffer, Emory) • NCT0184717- FMT effect on the IBD microbiome (Moss, Beth Israel) • NCT01947101 – FMT as a transition off immunosuppression with stable UC (Kellermeyer, Baylor)

  32. Summary • FMT appears safe and well tolerated in children independent of route • Efficacious for RCDI • Mixed response in IBD • Best route ? • Pre-FMT antibiotics ? • Donor matching ? • Durability / maintenance ?

  33. The road ahead

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