FMT in Pediatric Crohn's Disease

The Investigators hypothesize that children with Crohn's disease who are in remission can
receive a single endoscopic dose of FMT with no significant safety concerns.

All children will receive the equivalent of 50 g of stools from a healthy donor into the
jejunum through upper endoscopy. Children will be seen at baseline, then 4 and 24 weeks after
study drug administration begins. Stools will be collected and stored for gut microbial
profiles during the study visit windows. In addition, a follow up telephone call will be
performed 7 days after study drug is administered. If children undergo endoscopy as part of
the standard of care, study staff will obtain 1-2 additional biopsies for evaluation of
mucosal inflammation. This study will also capture any laboratory results if any of the
subjects undergo laboratory testing as part of the standard of care. This study will define
the effects of transplant on gut microbial profile using advanced molecular taxonomic
approaches. Safety will be closely monitored by solicited (during defined telephone calls and
study visits) and unsolicited adverse events (at all times). Safety will be the primary
endpoint of this study. Secondary endpoints include Pediatric Crohn's Disease Activity Index
(PCDAI), changes in gut microbial diversity - determined by gut microbial genomics and
proteomics (16S ribosomal RNA, 16s rRNA), and outcome measures for mucosal inflammation and
repair as reflected through laboratory testing such as the level for C-reactive protein
(CRP), erythrocyte sedimentation rate (ESR), inflammatory cytokines of the colonic mucosa as
well as the stool calprotectin level.

Inclusion Criteria:

1. Age: 7-21 who have been diagnosed with Crohn's disease

2. Remission of disease defined as PCDAI <10

3. Needs upper GI endoscopy

Exclusion Criteria:

1. Unwilling to give informed consent/assent

2. Pregnancy and breast feeding in patient subjects of childbearing potential

3. Subjects with significant renal and liver dysfunction (creatinine > 2 mg/dl and direct
bilirubin > 2 mg/dl)

4. Subjects with congenital or acquired immunodeficiency, or who are immunosuppressed due
to conditions other than Crohn's disease (such as neoplastic disease or organ
transplantation), have received or are receiving chemotherapy, or have been diagnosed
with HIV.

5. Subjects with severe food allergies