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

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Presentation on theme: "FMT in Pediatric IBD Michael Docktor, MD Boston Children’s Hospital August 16, 2014."— Presentation transcript:

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 2

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

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

5 Our experience: FMT for IBD “Innovative Therapy” 7 patients with recalcitrant IBD –Ages 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 Unpublished data

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 Unpublished data

7 Microbial analysis of FMT Docktor M, et al. Unpublished data

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 8 Russell GH, et al. JPGN. 2014; 58(5):

9

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

11 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?

12 Fecal Microbiota Transplantation in Children with Recurrent Clostridium difficile Infection Anne Pierog, MD, Ali Mencin, MD, and Norelle Rizkalla Reilly, MD Columbia University Medical Center, Division of Pediatric Gastroenterology, Hepatology and Nutrition 6 patients with RCDI –Ages 4-21 yrs., 4 M / 2 F –1 CD, 1 IC –Related donor FMT via colonoscopy 100% cure rate for C. diff 12 y/o M with CD –Initial clinical 1 week –Acute 2 weeks post FMT –Clinical “remission” with optimized 12 weeks Follow up: both IBD patients cured of CDI, required escalation of IBD therapy 12 Pierog A, et al. Peds Infec 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 feasible and tolerable in children with limited side effects. Kunde S, et al. JPGN 2013 Jun;56(6):

15

16 Fecal Microbial Transplant via Nasogastric tube for active Pediatric Ulcerative Colitis David L. Suskind 1 M.D., Namita Singh 2 M.D., Heather Nielson, Ghassan Wahbeh 1 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 2, 6, 12 weeks –Mild symptoms including vomiting and bloating –2/4 developed C.diff within 4 months (1 recurrence) –No change in PUCAI, CRP, albumin, HCT Overall safe but not efficacious 16 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’s disease David L. Suskind MD 1, Mitchell J. Brittnacher PhD 2, Ghassan Wahbeh MD 1, Michele L. Shaffer PhD 1, Hillary S. Hayden 2, Namita Singh MD 3, Christopher J. Damman MD 4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD 2,4,5,6 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 18 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’s disease David L. Suskind MD 1, Mitchell J. Brittnacher PhD 2, Ghassan Wahbeh MD 1, Michele L. Shaffer PhD 1, Hillary S. Hayden 2, Namita Singh MD 3, Christopher J. Damman MD 4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD 2,4,5,6

20 7/9 (78%) Had PCDAI fall < 2 weeks –2 required escalation of Rx 5/7 (71%) Remained < 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. Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohn’s disease David L. Suskind MD 1, Mitchell J. Brittnacher PhD 2, Ghassan Wahbeh MD 1, Michele L. Shaffer PhD 1, Hillary S. Hayden 2, Namita Singh MD 3, Christopher J. Damman MD 4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD 2,4,5,6

21 21 Recipient Similarity to donor % Suskind DL, et al. Seattle Children’s Hospital. Data in submission for print. Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohn’s disease David L. Suskind MD 1, Mitchell J. Brittnacher PhD 2, Ghassan Wahbeh MD 1, Michele L. Shaffer PhD 1, Hillary S. Hayden 2, Namita Singh MD 3, Christopher J. Damman MD 4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD 2,4,5,6 Time relative to FMT (days)

22 22 Engraftment score (% ) Suskind DL, et al. Seattle Children’s Hospital. Data in submission for print. Time relative to FMT (days) Fecal Microbial Transplant Effect on Clinical Outcomes and Fecal Microbiome in Active Crohn’s disease David L. Suskind MD 1, Mitchell J. Brittnacher PhD 2, Ghassan Wahbeh MD 1, Michele L. Shaffer PhD 1, Hillary S. Hayden 2, Namita Singh MD 3, Christopher J. Damman MD 4, Kyle R. Hager, Heather Nielson, Samuel I. Miller MD 2,4,5,6

23 Vandenplas Y, et al. JPGN /MPG Fecal microbial transplantation in a one-year- old girl with early onset colitis - caution advised Vandenplas Y, Veereman G, van der Werff ten Bosch J, A. Goossens, Pierard D, Samsom JN, Escher JC

24 Vandenplas Y, et al. JPGN /MPG

25 Every 2 weeks FMT From healthy age matched niece days of remission Vandenplas Y, et al. JPGN /MPG

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

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

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

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

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

31 Clinical Trials NCT – DBPCT using FMT to treat chronic active UC (Padaramothy, New South Wales) NCT – FMT to treat active UC associated post-IPAA pouchitis (Shaffer, Emory) NCT FMT effect on the IBD microbiome (Moss, Beth Israel) NCT – 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 ? 32

33 The road ahead 33


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