This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment
Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN in the treatment of refractory pediatric CD. In the induction stage of CD, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 1-2 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course, and the withdrawal of conventional drug therapy was gradually reduced. Refractory CD was defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGClinical remission
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Time frame: 8-12 weeks after FMT
Endoscopic remission
Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2
Time frame: 8-12 weeks after FMT
Mucosal healing
Mucosal healing defined as SES-CD = 0
Time frame: 8-12 weeks after FMT
Adverse events
All possible adverse events:fever,abdominal pain,infectious diseases and others
Time frame: 2 and 8 weeks after FMT
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